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

Coronary Artery Disease Clinical Trial

— PEPCAD-CTO  

Official title:

The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670436
• Other study ID #: PEPCAD-CTO V 2.3
• Status: Completed
• Phase: Phase 2
• First received: April 29, 2008
• Last updated: June 7, 2014
• Start date: February 2008
• Est. completion date: March 2014

Study information

• Verified date: June 2014
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2014
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Total Occlusion
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Native Coronary Artery

Intervention

Device:
• paclitaxel eluting PTCA balloon catheter (SeQuent Please)
paclitaxel eluting PTCA balloon catheter after bare-metal stenting of chronic total occlusion in a native coronary artery
• paclitaxel eluting Taxus stent (Boston Scientific)
paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries

Locations

Country	Name	City	State
Germany	Klinikum Darmstadt	Darmstadt
Germany	University of Ulm	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulm	B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Wöhrle J, Werner GS. Paclitaxel-coated balloon with bare-metal stenting in patients with chronic total occlusions in native coronary arteries. Catheter Cardiovasc Interv. 2013 Apr;81(5):793-9. doi: 10.1002/ccd.24409. Epub 2012 Nov 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late loss		6 months	No
Secondary	percent diameter stenosis		6 months	No
Secondary	binary angiographic restenosis rate		6 months	No
Secondary	late loss index		6 months	No
Secondary	Target lumen revascularization		30 days, 6, 12, 24 months	No
Secondary	target vessel revascularization		30 days, 6, 12, 24 months	No
Secondary	major adverse cardiac events		30 days, 6, 12, 24 months	Yes