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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00670436

Acronym

PEPCAD-CTO

Enrollment

Registered

2008-05-01

Start date

2008-02-29

Completion date

2014-03-31

Last updated

2014-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Total Occlusion, Coronary Artery Disease, Native Coronary Artery

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.

Interventions

DEVICEpaclitaxel eluting PTCA balloon catheter (SeQuent Please)

paclitaxel eluting PTCA balloon catheter after bare-metal stenting of chronic total occlusion in a native coronary artery

DEVICEpaclitaxel eluting Taxus stent (Boston Scientific)

paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Late loss	6 months

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026