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Completed

NCT Number: NCT01166711

Treatment of Coronary Artery Disease (CAD) With Bare Metal Stent (BMS) Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent

The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Upper Silesian Heart Center

Katowice, 40-635, Poland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina and silent ischemia
  • Presence of one or more coronary artery stenosis >50% in a native coronary artery from 2.25 to 3.5 mm in diameter that can be covered with one stent
  • One lesion treated with the study device

Exclusion criteria

  • Pregnancy
  • Known intolerance to aspirin, clopidogrel, heparin, stainless steel, paclitaxel, cobalt, chromium or contrast material
  • Inability to provide informed consent
  • Currently participating in another trial before reaching the primary endpoint
  • Elective surgery within 12 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri-surgical period
  • Acute or recent myocardial infarction
  • left ventricular ejection fraction (LVEF) < 30 %
  • Stroke or transient ischemic attack within 6 months
  • Stented segment longer than 23 mm
  • Vessel diameter of less than 2,5 mm
  • Significant calcification, chronic total occlusion (CTO) or thrombus in the target lesion

Treatment and study plan

Coroflex Blue (BMS) followed by SeQuent Please (DEB)

Device
  • standard techniques will be used
  • maximal vasodilatation after nitro application
  • baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap)
  • 6 French guiding catheter at least
  • target lesion will be crossed with standard guidewire
  • direct stenting at the discretion of the investigator
  • if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted)
  • full lesion coverage will be ensured (with one or more stents)
  • only insert assigned stent type
  • BMS needs to be fully embedded in vessel wall
  • post-dilation with high pressure is required before treatment with DEB
  • DEB will be inflated with nominal pressure (balloon equates to vessel diameter)
  • length of DEB should exceed the BMS by 2-3 mm on each side
  • if dissection, full length of dissection and optional additional stented area should be treated with additional DEB (to avoid geographic miss)

Other names: Coroflex Blue, Cobalt Chromium stent, BMS, SeQuent Please, Paclitaxel-coated Balloon Catheter, DEB

Coroflex Please (DES)

Device
  • standard techniques will be used
  • maximal vasodilatation after nitro application
  • baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap)
  • 6 French guiding catheter at least
  • target lesion will be crossed with standard guidewire
  • direct stenting at the discretion of the investigator
  • if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted)
  • full lesion coverage will be ensured (with one or more stents)
  • only insert assigned stent type

Other names: Coroflex Please, Paclitaxel-Eluting Stent, DES

Primary outcomes

  1. Major adverse cardiac events (MACE) - target vessel failure (TVF)

    Time frame: 9 months

    consisting of the composite of cardiac death, myocardial infarction (Q-wave and Non-Q wave) localized at the territory supplied by the treated vessel or target vessel revascularization (TVR) by either percutaneous coronary intervention or bypass graft surgery in the overall population

Secondary outcomes

  1. Major adverse cardiac events (MACE)

    Time frame: 1 year

    defined as the composite of cardiovascular death, stroke, myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR), as well as the individual components of target vessel revascularization (TVR) and Major adverse cardiac events (MACE) and stent thrombosis

  2. in-stent binary restenosis

    Time frame: 9 months

    defined as >= 50 % diameter stenosis (% DS)

  3. Angiographic and clinical stent thrombosis

    Time frame: 30 days

  4. Angiographic and clinical stent thrombosis

    Time frame: 6 months

  5. Angiographic and clinical stent thrombosis

    Time frame: 9 months

  6. Angiographic and clinical stent thrombosis

    Time frame: 1 year

  7. Angiographic and clinical stent thrombosis

    Time frame: 2 years

  8. Angiographic and clinical stent thrombosis

    Time frame: 3 years

  9. In-stent and in-segment minimal luminal diameter (MLD)

    Time frame: 9 months

  10. In-segment percent diameter stenosis (%DS)

    Time frame: 9 months

  11. In-stent and in-segment late luminal loss

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

SeQuent 1000 - Treatment of Coronary Artery Disease With Bare Metal Stent Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent: Randomized Trial

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Jul 21, 2010
Registry last updated
Jan 10, 2018

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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