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

This study has been completed.
Sponsor:
Collaborator:
B. Braun Melsungen AG
Information provided by (Responsible Party):
Jochen Wohrle, University of Ulm
ClinicalTrials.gov Identifier:
NCT00670436
First received: April 29, 2008
Last updated: June 7, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Chronic Total Occlusion
Native Coronary Artery
Device: paclitaxel eluting PTCA balloon catheter (SeQuent Please)
Device: paclitaxel eluting Taxus stent (Boston Scientific)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Late loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • percent diameter stenosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • binary angiographic restenosis rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • late loss index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Target lumen revascularization [ Time Frame: 30 days, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • target vessel revascularization [ Time Frame: 30 days, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • major adverse cardiac events [ Time Frame: 30 days, 6, 12, 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: February 2008
Study Completion Date: March 2014
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A 1
paclitaxel eluting PTCA balloon (SeQuent please) after bare-metal stenting of a chronic total occlusion in a native coronary artery
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
Other Names:
  • SeQuent Please
  • paclitaxel eluting balloon
Active Comparator: A2
historical population of patients with a chronic total occlusion in a native coronary artery treated with the paclitaxel eluting Taxus stent (Boston Scientific)
Device: paclitaxel eluting Taxus stent (Boston Scientific)
paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670436

Locations
Germany
Klinikum Darmstadt
Darmstadt, Germany, 64283
University of Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
University of Ulm
B. Braun Melsungen AG
Investigators
Principal Investigator: Jochen Wöhrle, MD; FESC University of Ulm, Ulm, Germany
  More Information

Publications:
Responsible Party: Jochen Wohrle, Prof. Dr. Jochen Wöhrle, University of Ulm
ClinicalTrials.gov Identifier: NCT00670436     History of Changes
Other Study ID Numbers: PEPCAD-CTO V 2.3
Study First Received: April 29, 2008
Last Updated: June 7, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014