NCT00747357

INDICOR The Paclitaxel-Eluting PTCA-Balloon Catheter in Combination With a Cobalt-Chromium Stent

The Paclitaxel-Eluting PTCA-Balloon Catheter in Combination With a Cobalt-Chromium Stent to Treat Coronary Artery Disease in a Real World Scenario

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Ralf Degenhardt, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Coronary Heart Diseases

Interventions

Type	Name	Description
DEVICE	Drug Eluting Balloon SeQuent Please	Drug Eluting Balloon is followed by Bare Metal Stent
DEVICE	Drug Eluting Balloon SeQuent Please	Bare Metal Stent followed by Drug Eluting Balloon

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-09-01
• Completion: 2016-01-01
• First posted: 2008-09-05
• Last updated: 2016-02-19

Locations

1 site across 1 country: India