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OpenTrials
Completed

NCT Number: NCT00670436

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chronic Total Occlusion Coronary Disease Heart Diseases Myocardial Ischemia Native Coronary Artery Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Klinikum Darmstadt, Darmstadt, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel eluting PTCA balloon catheter (SeQuent Please)

Device

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

paclitaxel eluting Taxus stent (Boston Scientific)

Device

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

Primary outcomes

  1. Late loss

    Time frame: 6 months

Secondary outcomes

  1. percent diameter stenosis

    Time frame: 6 months

  2. binary angiographic restenosis rate

    Time frame: 6 months

  3. late loss index

    Time frame: 6 months

  4. Target lumen revascularization

    Time frame: 30 days, 6, 12, 24 months

  5. target vessel revascularization

    Time frame: 30 days, 6, 12, 24 months

  6. major adverse cardiac events

    Time frame: 30 days, 6, 12, 24 months

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Collaborators

  • B. Braun Melsungen AG

Registry information

Official study title

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

Acronym: PEPCAD-CTO

Important dates

Study start
2008
Primary completion
2009
Study completion
2014
First posted
May 1, 2008
Registry last updated
Jun 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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