747357
Last Update Posted: 2016-02-19
Recruiting has ended
All Genders accepted | 18 Years + |
97 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
INDICOR The Paclitaxel-Eluting PTCA-Balloon Catheter in Combination With a Cobalt-Chromium Stent
The INDICOR study is a controlled, prospective, multicenter, randomized, two arm phase-II real world study assessing the acute, 6 months, and 12 months and 3 year outcome of cobalt-chromium stent (Coroflex Blue) deployment followed by Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) and of Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) followed by cobalt-chromium stent (Coroflex Blue) deployment for the treatment of de-novo and restenotic lesions in native coronary arteries. The study will be conducted in India.
The aim of the study is to evaluate the efficacy and safety of cobalt-chromium stent (Coroflex Blue) deployment followed by Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) and of Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) followed by cobalt-chromium stent (Coroflex Blue) deployment in a real world scenario including up to two de-novo or restenotic lesions ( no in-stent restenoses) in two different native coronary arteries (reference diameter: 2.5mm and 4.0mm, length of stenosis 10mm and 25mm) for procedural success and preservation of vessel patency up to 3 years
Eligibility
Relevant conditions:
Coronary Heart Diseases
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov