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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aesculap AG
ClinicalTrials.gov Identifier:
NCT01166711
First received: July 20, 2010
Last updated: October 15, 2012
Last verified: October 2012

July 20, 2010
October 15, 2012
August 2010
February 2013   (final data collection date for primary outcome measure)
Major adverse cardiac events (MACE) - target vessel failure (TVF) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01166711 on ClinicalTrials.gov Archive Site
  • Major adverse cardiac events (MACE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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
  • in-stent binary restenosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    defined as >= 50 % diameter stenosis (% DS)
  • Angiographic and clinical stent thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Angiographic and clinical stent thrombosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Angiographic and clinical stent thrombosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Angiographic and clinical stent thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Angiographic and clinical stent thrombosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Angiographic and clinical stent thrombosis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • In-stent and in-segment minimal luminal diameter (MLD) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • In-segment percent diameter stenosis (%DS) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • In-stent and in-segment late luminal loss [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • MACE [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    defined as the composite of cardiovascular death, stroke, MI or ischemia-driven target lesion revascularization (TLR), as well as the individual components of TVR and MACE and stent thrombosis
  • in-stent binary restenosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    defined as >= 50 % diameter stenosis (% DS)
  • Angiographic and clinical stent thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Angiographic and clinical stent thrombosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Angiographic and clinical stent thrombosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Angiographic and clinical stent thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Angiographic and clinical stent thrombosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Angiographic and clinical stent thrombosis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • In-stent and in-segment minimal luminal diameter (MLD) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • In-segment percent diameter stenosis (%DS) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • In-stent and in-segment late luminal loss [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Treatment of Coronary Artery Disease (CAD) With Bare Metal Stent (BMS) Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent
SeQuent 1000 - Treatment of Coronary Artery Disease With Bare Metal Stent Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent: Randomized Trial

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: Coroflex Blue (BMS) followed by SeQuent Please (DEB)
    • 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
  • Device: Coroflex Please (DES)
    • 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
  • Experimental: Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB)
    Intervention: Device: Coroflex Blue (BMS) followed by SeQuent Please (DEB)
  • Active Comparator: Drug Eluting Stent (DES)
    Intervention: Device: Coroflex Please (DES)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
April 2015
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01166711
SEQUENT 1000
No
Aesculap AG
Aesculap AG
Not Provided
Principal Investigator: Paweł E. Buszman, MD, PhD American Heart of Poland, Katowice
Aesculap AG
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP