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

University of Ulm

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease; Native Coronary Artery; Chronic Total Occlusion

Treatments: Device: paclitaxel eluting Taxus stent (Boston Scientific); Device: paclitaxel eluting PTCA balloon catheter (SeQuent Please)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00670436

PEPCAD-CTO V 2.3

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups

A 1

Active Comparator group

Description:

paclitaxel eluting PTCA balloon (SeQuent please) after bare-metal stenting of a chronic total occlusion in a native coronary artery

Treatment:

Device: paclitaxel eluting PTCA balloon catheter (SeQuent Please)

A2

Active Comparator group

Description:

historical population of patients with a chronic total occlusion in a native coronary artery treated with the paclitaxel eluting Taxus stent (Boston Scientific)

Treatment:

Device: paclitaxel eluting Taxus stent (Boston Scientific)