The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions

Phase 2

Completed

• Conditions: Chronic Total Occlusion; Coronary Artery Disease; Native Coronary Artery
• Interventions: Device: paclitaxel eluting PTCA balloon catheter (SeQuent Please); Device: paclitaxel eluting Taxus stent (Boston Scientific)

• Registration Number: NCT00670436
• Lead Sponsor: University of Ulm

Brief Summary

The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-04-30
• Study First Posted: 2008-05-01
• Primary Completion: 2009-09
• Study Completion: 2014-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-07
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• chronic total occlusion
• Thrombolysis in Myocardial Infarction (TIMI) flow 0 or 1
• occlusion in native coronary artery
• indication for percutaneous coronary intervention based on symptoms, prognosis or evidence of ischemia
• reference diameter 2.5 mm to 4.0 mm

Exclusion Criteria

• saphenous vein graft
• bifurcation lesion with need to stent main and side branch
• left main occlusion
• de-novo stenosis (no occlusion)
• restenosis
• in-stent restenosis
• contraindication for dual antiplatelet therapy with acetylsalicylic acid and clopidogrel for 6 months
• coronary aneurysm at target lesion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A 1	paclitaxel eluting PTCA balloon catheter (SeQuent Please)	paclitaxel eluting PTCA balloon (SeQuent please) after bare-metal stenting of a chronic total occlusion in a native coronary artery
A2	paclitaxel eluting Taxus stent (Boston Scientific)	historical population of patients with a chronic total occlusion in a native coronary artery treated with the paclitaxel eluting Taxus stent (Boston Scientific)

Primary Outcome Measures

Name	Time	Method
Late loss	6 months

Secondary Outcome Measures

Name	Time	Method
percent diameter stenosis	6 months
late loss index	6 months
target vessel revascularization	30 days, 6, 12, 24 months
major adverse cardiac events	30 days, 6, 12, 24 months
binary angiographic restenosis rate	6 months
Target lumen revascularization	30 days, 6, 12, 24 months

Trial Locations

Locations (2)

Klinikum Darmstadt; 🇩🇪 Darmstadt, Germany

University of Ulm; 🇩🇪 Ulm, Germany