{"id":{"repo_id":"aachen","oai_identifier":"oai:publications.rwth-aachen.de:61649"},"canonical_url":"https://search.dev.ndltd.org/etd/aachen/oai:publications.rwth-aachen.de:61649","repository":{"repo_id":"aachen","name":"RWTH Aachen University","base_url":"https://publications.rwth-aachen.de/oai2d"},"display":{"title":"Endovaskuläre Brachytherapie mit Rhenium-188 zur Prophylaxe einer Restenose nach perkutaner transluminaler Angioplastie im peripheren Stromgebiet : klinische Studie und Literaturübersicht","abstract":"The objective of this prospective placebo controlled study which was realized in cooperation with the department of nuclear medicine of the clinical centre of Ulm from 30.10.2001 to 02.10.2003 was to examine the efficacy of a PTA balloon filled with the ß-radiator rhenium 188 in order to prevent a restenosis in the femoropopliteal artery. Furthermore, to determine the individually required doses of rhenium 188 by intravascular ultrasound (IVUS) measurements of plaque morphology as well as to present an overview of current literature. By angiographic imaging of the stenotic femoropopliteal artery of 17 patients (18 vessels) with an average age of 75,2 ± 7,99, the length (ø toto:14,1 mm; ø verum:14,1 mm; ø placebo:14,0 mm) and grade of stenosis before (ø T:88,2%; ø V:84,7%; ø P:90,5%) and after (ø T:19%; ø V:21%; ø P:18%) percutaneous transluminal angioplasty was measured. Subsequently the media-adventitia distance (ø T: 1,92 mm; ø V:1,90 mm; ø P:1,94 mm), intima media distance(ø T:0,81 mm; ø V:0,81 mm; ø P:0,80 mm), lumen area (ø T:15,0 mm2; ø V:15,5 mm2; ø P:14,7 mm2) and vessel area (ø T:39,8 mm2; ø V:39,9 mm2; ø P:39,8 mm2) were measured and displayed using IVUS in the dilated section of the vessel. The dilated vessel section was radiated after the calculation of the doses and the required radiation time for the verum group based on vessel morphology. During the average radiation time of 14,03 minutes (7,12 min to 26,23 min) with an average Rhenium-188 activity of 3683,6 MBq/ml (1524,26 MBq/ml - 5643,09 MBq/ml) a minimum dose of 10 Gray (Gy) at the spot of maximum media adventitia distance (ø 1,90 mm; 1,8 mm to 2,2 mm) was not undercut and respectively a maximum dose of 40 Gy at the spot of minimum intima media distance (ø 0,81 mm; 0,6 mm to 1,2 mm) was not exceeded. Verum as well as the non-radiated placebo group were examined three times during the follow-up period to detect the incidence of restenosis of the treated vessel section. A continuous anticoagulative medication (75 mg Plavix®/Iscover® and ASS 100mg) was taken. After a mean follow-up period of 14,6 months, the verum group showed a restenosis rate of 28,6% (2 vessels) while the placebo group respectively showed a rate of 45,5% (5 vessels). Angiographic as well as IVUS dissection rate in the verum group (42,9% vs. 71,4%) was less than in the placebo group (63,6% vs. 81,8%). Cases lacking a restenosis during follow up showed a dissection rate of 63,3% in angiographic post PTA and 81,8% in IVUS, while cases with restenosis showed a rate of 42,8% in angiography and 71,4% in IVUS. Therefore a lesser dissection rate does not prevent restenosis. After the follow-up period, the verum group showed a mean lumen loss of 1,1 mm (24,64% ± 16,55%; Median 27,50%) while the placebo group showed a mean lumen loss of 1,37 mm (25,28% ± 21,25%; Median: 29,87%). The range of reduction rate was found to be between 0% and 41,38% in verum group and 0% to 59,09% in the placebo group. Mean ankle brachial index measured by Doppler ultrasonography showed a value of 0,95 (0,71 - 1,17; Median: 0,96) in the verum group and of 0,85 (0,56 - 1,47; Median: 0,81) in the placebo group, peak systolic velocity (PSV) in the verum group showed values between 1,20 and 2,16 (Mean: 1,62; Median: 1,59) and between 0,50 and 3,08 (Mean: 1,63; Median: 1,50) in the placebo group. There were no cases of late thrombosis in the verum or placebo group due to an extended mean anticoagulative therapy with ASS und Plavix®/Iscover® of 14,6 months. In our study endovascular brachytherapy with a Rhenium-188 filled PTA balloon was a feasible and safe alternative to primarily used techniques of endovascular radiation for the physician as well as the patient. At no point was any personnel exposed to elevated radiation, there was no Rhenium-188 leakage in any PTA balloon. There were no complications in our verum group during treatment or follow-up period. Thus, despite overall positive results studies with a larger number of patients should follow due to the reduced number in our study.","abstract_html":"The objective of this prospective placebo controlled study which was realized in cooperation with the department of nuclear medicine of the clinical centre of Ulm from 30.10.2001 to 02.10.2003 was to examine the efficacy of a PTA balloon filled with the ß-radiator rhenium 188 in order to prevent a restenosis in the femoropopliteal artery. Furthermore, to determine the individually required doses of rhenium 188 by intravascular ultrasound (IVUS) measurements of plaque morphology as well as to present an overview of current literature. By angiographic imaging of the stenotic femoropopliteal artery of 17 patients (18 vessels) with an average age of 75,2 ± 7,99, the length (ø toto:14,1 mm; ø verum:14,1 mm; ø placebo:14,0 mm) and grade of stenosis before (ø T:88,2%; ø V:84,7%; ø P:90,5%) and after (ø T:19%; ø V:21%; ø P:18%) percutaneous transluminal angioplasty was measured. Subsequently the media-adventitia distance (ø T: 1,92 mm; ø V:1,90 mm; ø P:1,94 mm), intima media distance(ø T:0,81 mm; ø V:0,81 mm; ø P:0,80 mm), lumen area (ø T:15,0 mm2; ø V:15,5 mm2; ø P:14,7 mm2) and vessel area (ø T:39,8 mm2; ø V:39,9 mm2; ø P:39,8 mm2) were measured and displayed using IVUS in the dilated section of the vessel. The dilated vessel section was radiated after the calculation of the doses and the required radiation time for the verum group based on vessel morphology. During the average radiation time of 14,03 minutes (7,12 min to 26,23 min) with an average Rhenium-188 activity of 3683,6 MBq/ml (1524,26 MBq/ml - 5643,09 MBq/ml) a minimum dose of 10 Gray (Gy) at the spot of maximum media adventitia distance (ø 1,90 mm; 1,8 mm to 2,2 mm) was not undercut and respectively a maximum dose of 40 Gy at the spot of minimum intima media distance (ø 0,81 mm; 0,6 mm to 1,2 mm) was not exceeded. Verum as well as the non-radiated placebo group were examined three times during the follow-up period to detect the incidence of restenosis of the treated vessel section. A continuous anticoagulative medication (75 mg Plavix®/Iscover® and ASS 100mg) was taken. After a mean follow-up period of 14,6 months, the verum group showed a restenosis rate of 28,6% (2 vessels) while the placebo group respectively showed a rate of 45,5% (5 vessels). Angiographic as well as IVUS dissection rate in the verum group (42,9% vs. 71,4%) was less than in the placebo group (63,6% vs. 81,8%). Cases lacking a restenosis during follow up showed a dissection rate of 63,3% in angiographic post PTA and 81,8% in IVUS, while cases with restenosis showed a rate of 42,8% in angiography and 71,4% in IVUS. Therefore a lesser dissection rate does not prevent restenosis. After the follow-up period, the verum group showed a mean lumen loss of 1,1 mm (24,64% ± 16,55%; Median 27,50%) while the placebo group showed a mean lumen loss of 1,37 mm (25,28% ± 21,25%; Median: 29,87%). The range of reduction rate was found to be between 0% and 41,38% in verum group and 0% to 59,09% in the placebo group. Mean ankle brachial index measured by Doppler ultrasonography showed a value of 0,95 (0,71 - 1,17; Median: 0,96) in the verum group and of 0,85 (0,56 - 1,47; Median: 0,81) in the placebo group, peak systolic velocity (PSV) in the verum group showed values between 1,20 and 2,16 (Mean: 1,62; Median: 1,59) and between 0,50 and 3,08 (Mean: 1,63; Median: 1,50) in the placebo group. There were no cases of late thrombosis in the verum or placebo group due to an extended mean anticoagulative therapy with ASS und Plavix®/Iscover® of 14,6 months. In our study endovascular brachytherapy with a Rhenium-188 filled PTA balloon was a feasible and safe alternative to primarily used techniques of endovascular radiation for the physician as well as the patient. At no point was any personnel exposed to elevated radiation, there was no Rhenium-188 leakage in any PTA balloon. There were no complications in our verum group during treatment or follow-up period. Thus, despite overall positive results studies with a larger number of patients should follow due to the reduced number in our study.","abstract_has_math":false,"creators":["Weissig, Thomas"],"institution":"Publikationsserver der RWTH Aachen University","degree_name":null,"degree_level":null,"degree_discipline":null,"degree_department":null,"school":null,"contributors":["Bohndorf, Klaus"],"advisors":[],"committee_chairs":[],"committee_members":[],"year":2006,"date_issued":"2006","date_published":"2006","updated_at":"2026-07-30T19:43:10Z","subjects":["info:eu-repo/classification/ddc/610","Medizin","Rhenium-188","Rhenium","Brachytherapie","Restenose","Perkutane transluminale Angioplastie","Periphere arterielle Verschlusskrankheit","Tunica intima","Brachytherapy","Restenosis","Angioplasty"],"languages":["ger"],"rights":["info:eu-repo/semantics/openAccess"],"rights_urls":[],"identifier_entries":[{"key":"dc:identifier","label":"Identifier","values":["https://publications.rwth-aachen.de/search?p=id:%22RWTH-CONV-123289%22"],"render_values":[{"text":"https://publications.rwth-aachen.de/search?p=id:%22RWTH-CONV-123289%22","href":"https://publications.rwth-aachen.de/search?p=id:%22RWTH-CONV-123289%22","code":true}]}]},"links":{"outbound_url":"https://publications.rwth-aachen.de/record/61649","outbound_label":"Repository record","outbound_source":"dc:identifier"},"metadata_groups":[{"id":"people","label":"People","entries":[{"key":"dc:contributor","label":"Contributor","values":["Bohndorf, Klaus"]},{"key":"dc:creator","label":"Author","values":["Weissig, Thomas"]}]},{"id":"academic_context","label":"Academic Context","entries":[{"key":"dc:coverage","label":"Dc Coverage","values":["DE"]},{"key":"dc:date","label":"Dc Date","values":["2006"]},{"key":"dc:publisher","label":"Institution","values":["Publikationsserver der RWTH Aachen University"]},{"key":"dc:relation","label":"Dc Relation","values":["info:eu-repo/semantics/altIdentifier/urn/urn:nbn:de:hbz:82-opus-17869"]},{"key":"dc:type","label":"Dc Type","values":["info:eu-repo/semantics/doctoralThesis","info:eu-repo/semantics/publishedVersion"]}]},{"id":"subjects_keywords","label":"Subjects and Keywords","entries":[{"key":"dc:subject","label":"Dc Subject","values":["info:eu-repo/classification/ddc/610","Medizin","Rhenium-188","Rhenium","Brachytherapie","Restenose","Perkutane transluminale Angioplastie","Periphere arterielle Verschlusskrankheit","Tunica intima","Brachytherapy","Restenosis","Angioplasty"]}]},{"id":"language_rights","label":"Language and Rights","entries":[{"key":"dc:language","label":"Dc Language","values":["ger"]},{"key":"dc:rights","label":"Dc Rights","values":["info:eu-repo/semantics/openAccess"]}]},{"id":"identifiers","label":"Identifiers","entries":[{"key":"dc:identifier","label":"Identifier","values":["https://publications.rwth-aachen.de/record/61649","https://publications.rwth-aachen.de/search?p=id:%22RWTH-CONV-123289%22"]}]},{"id":"additional","label":"Additional Metadata","entries":[{"key":"dc:description","label":"Description","values":["The objective of this prospective placebo controlled study which was realized in cooperation with the department of nuclear medicine of the clinical centre of Ulm from 30.10.2001 to 02.10.2003 was to examine the efficacy of a PTA balloon filled with the ß-radiator rhenium 188 in order to prevent a restenosis in the femoropopliteal artery. Furthermore, to determine the individually required doses of rhenium 188 by intravascular ultrasound (IVUS) measurements of plaque morphology as well as to present an overview of current literature. By angiographic imaging of the stenotic femoropopliteal artery of 17 patients (18 vessels) with an average age of 75,2 ± 7,99, the length (ø toto:14,1 mm; ø verum:14,1 mm; ø placebo:14,0 mm) and grade of stenosis before (ø T:88,2%; ø V:84,7%; ø P:90,5%) and after (ø T:19%; ø V:21%; ø P:18%) percutaneous transluminal angioplasty was measured. Subsequently the media-adventitia distance (ø T: 1,92 mm; ø V:1,90 mm; ø P:1,94 mm), intima media distance(ø T:0,81 mm; ø V:0,81 mm; ø P:0,80 mm), lumen area (ø T:15,0 mm2; ø V:15,5 mm2; ø P:14,7 mm2) and vessel area (ø T:39,8 mm2; ø V:39,9 mm2; ø P:39,8 mm2) were measured and displayed using IVUS in the dilated section of the vessel. The dilated vessel section was radiated after the calculation of the doses and the required radiation time for the verum group based on vessel morphology. During the average radiation time of 14,03 minutes (7,12 min to 26,23 min) with an average Rhenium-188 activity of 3683,6 MBq/ml (1524,26 MBq/ml - 5643,09 MBq/ml) a minimum dose of 10 Gray (Gy) at the spot of maximum media adventitia distance (ø 1,90 mm; 1,8 mm to 2,2 mm) was not undercut and respectively a maximum dose of 40 Gy at the spot of minimum intima media distance (ø 0,81 mm; 0,6 mm to 1,2 mm) was not exceeded. Verum as well as the non-radiated placebo group were examined three times during the follow-up period to detect the incidence of restenosis of the treated vessel section. A continuous anticoagulative medication (75 mg Plavix®/Iscover® and ASS 100mg) was taken. After a mean follow-up period of 14,6 months, the verum group showed a restenosis rate of 28,6% (2 vessels) while the placebo group respectively showed a rate of 45,5% (5 vessels). Angiographic as well as IVUS dissection rate in the verum group (42,9% vs. 71,4%) was less than in the placebo group (63,6% vs. 81,8%). Cases lacking a restenosis during follow up showed a dissection rate of 63,3% in angiographic post PTA and 81,8% in IVUS, while cases with restenosis showed a rate of 42,8% in angiography and 71,4% in IVUS. Therefore a lesser dissection rate does not prevent restenosis. After the follow-up period, the verum group showed a mean lumen loss of 1,1 mm (24,64% ± 16,55%; Median 27,50%) while the placebo group showed a mean lumen loss of 1,37 mm (25,28% ± 21,25%; Median: 29,87%). The range of reduction rate was found to be between 0% and 41,38% in verum group and 0% to 59,09% in the placebo group. Mean ankle brachial index measured by Doppler ultrasonography showed a value of 0,95 (0,71 - 1,17; Median: 0,96) in the verum group and of 0,85 (0,56 - 1,47; Median: 0,81) in the placebo group, peak systolic velocity (PSV) in the verum group showed values between 1,20 and 2,16 (Mean: 1,62; Median: 1,59) and between 0,50 and 3,08 (Mean: 1,63; Median: 1,50) in the placebo group. There were no cases of late thrombosis in the verum or placebo group due to an extended mean anticoagulative therapy with ASS und Plavix®/Iscover® of 14,6 months. In our study endovascular brachytherapy with a Rhenium-188 filled PTA balloon was a feasible and safe alternative to primarily used techniques of endovascular radiation for the physician as well as the patient. At no point was any personnel exposed to elevated radiation, there was no Rhenium-188 leakage in any PTA balloon. There were no complications in our verum group during treatment or follow-up period. Thus, despite overall positive results studies with a larger number of patients should follow due to the reduced number in our study."]},{"key":"dc:source","label":"Dc Source","values":["Aachen : Publikationsserver der RWTH Aachen University 100 S. : Ill., graph. Darst. (2006). = Aachen, Techn. Hochsch., Diss., 2006"]},{"key":"dc:title","label":"Title","values":["Endovaskuläre Brachytherapie mit Rhenium-188 zur Prophylaxe einer Restenose nach perkutaner transluminaler Angioplastie im peripheren Stromgebiet : klinische Studie und Literaturübersicht"]}]}],"canonical_facts":{"dc:contributor":["Bohndorf, Klaus"],"dc:coverage":["DE"],"dc:creator":["Weissig, Thomas"],"dc:date":["2006"],"dc:description":["The objective of this prospective placebo controlled study which was realized in cooperation with the department of nuclear medicine of the clinical centre of Ulm from 30.10.2001 to 02.10.2003 was to examine the efficacy of a PTA balloon filled with the ß-radiator rhenium 188 in order to prevent a restenosis in the femoropopliteal artery. Furthermore, to determine the individually required doses of rhenium 188 by intravascular ultrasound (IVUS) measurements of plaque morphology as well as to present an overview of current literature. By angiographic imaging of the stenotic femoropopliteal artery of 17 patients (18 vessels) with an average age of 75,2 ± 7,99, the length (ø toto:14,1 mm; ø verum:14,1 mm; ø placebo:14,0 mm) and grade of stenosis before (ø T:88,2%; ø V:84,7%; ø P:90,5%) and after (ø T:19%; ø V:21%; ø P:18%) percutaneous transluminal angioplasty was measured. Subsequently the media-adventitia distance (ø T: 1,92 mm; ø V:1,90 mm; ø P:1,94 mm), intima media distance(ø T:0,81 mm; ø V:0,81 mm; ø P:0,80 mm), lumen area (ø T:15,0 mm2; ø V:15,5 mm2; ø P:14,7 mm2) and vessel area (ø T:39,8 mm2; ø V:39,9 mm2; ø P:39,8 mm2) were measured and displayed using IVUS in the dilated section of the vessel. The dilated vessel section was radiated after the calculation of the doses and the required radiation time for the verum group based on vessel morphology. During the average radiation time of 14,03 minutes (7,12 min to 26,23 min) with an average Rhenium-188 activity of 3683,6 MBq/ml (1524,26 MBq/ml - 5643,09 MBq/ml) a minimum dose of 10 Gray (Gy) at the spot of maximum media adventitia distance (ø 1,90 mm; 1,8 mm to 2,2 mm) was not undercut and respectively a maximum dose of 40 Gy at the spot of minimum intima media distance (ø 0,81 mm; 0,6 mm to 1,2 mm) was not exceeded. Verum as well as the non-radiated placebo group were examined three times during the follow-up period to detect the incidence of restenosis of the treated vessel section. A continuous anticoagulative medication (75 mg Plavix®/Iscover® and ASS 100mg) was taken. After a mean follow-up period of 14,6 months, the verum group showed a restenosis rate of 28,6% (2 vessels) while the placebo group respectively showed a rate of 45,5% (5 vessels). Angiographic as well as IVUS dissection rate in the verum group (42,9% vs. 71,4%) was less than in the placebo group (63,6% vs. 81,8%). Cases lacking a restenosis during follow up showed a dissection rate of 63,3% in angiographic post PTA and 81,8% in IVUS, while cases with restenosis showed a rate of 42,8% in angiography and 71,4% in IVUS. Therefore a lesser dissection rate does not prevent restenosis. After the follow-up period, the verum group showed a mean lumen loss of 1,1 mm (24,64% ± 16,55%; Median 27,50%) while the placebo group showed a mean lumen loss of 1,37 mm (25,28% ± 21,25%; Median: 29,87%). The range of reduction rate was found to be between 0% and 41,38% in verum group and 0% to 59,09% in the placebo group. Mean ankle brachial index measured by Doppler ultrasonography showed a value of 0,95 (0,71 - 1,17; Median: 0,96) in the verum group and of 0,85 (0,56 - 1,47; Median: 0,81) in the placebo group, peak systolic velocity (PSV) in the verum group showed values between 1,20 and 2,16 (Mean: 1,62; Median: 1,59) and between 0,50 and 3,08 (Mean: 1,63; Median: 1,50) in the placebo group. There were no cases of late thrombosis in the verum or placebo group due to an extended mean anticoagulative therapy with ASS und Plavix®/Iscover® of 14,6 months. In our study endovascular brachytherapy with a Rhenium-188 filled PTA balloon was a feasible and safe alternative to primarily used techniques of endovascular radiation for the physician as well as the patient. At no point was any personnel exposed to elevated radiation, there was no Rhenium-188 leakage in any PTA balloon. There were no complications in our verum group during treatment or follow-up period. Thus, despite overall positive results studies with a larger number of patients should follow due to the reduced number in our study."],"dc:identifier":["https://publications.rwth-aachen.de/record/61649","https://publications.rwth-aachen.de/search?p=id:%22RWTH-CONV-123289%22"],"dc:language":["ger"],"dc:publisher":["Publikationsserver der RWTH Aachen University"],"dc:relation":["info:eu-repo/semantics/altIdentifier/urn/urn:nbn:de:hbz:82-opus-17869"],"dc:rights":["info:eu-repo/semantics/openAccess"],"dc:source":["Aachen : Publikationsserver der RWTH Aachen University 100 S. : Ill., graph. Darst. (2006). = Aachen, Techn. Hochsch., Diss., 2006"],"dc:subject":["info:eu-repo/classification/ddc/610","Medizin","Rhenium-188","Rhenium","Brachytherapie","Restenose","Perkutane transluminale Angioplastie","Periphere arterielle Verschlusskrankheit","Tunica intima","Brachytherapy","Restenosis","Angioplasty"],"dc:title":["Endovaskuläre Brachytherapie mit Rhenium-188 zur Prophylaxe einer Restenose nach perkutaner transluminaler Angioplastie im peripheren Stromgebiet : klinische Studie und Literaturübersicht"],"dc:type":["info:eu-repo/semantics/doctoralThesis","info:eu-repo/semantics/publishedVersion"]},"updated_at":"2026-07-30T19:43:10Z"}