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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: Coroflex Blue (BMS) followed by SeQuent Please (DEB)
Device: Coroflex Please (DES)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: SeQuent 1000 - Treatment of Coronary Artery Disease With Bare Metal Stent Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent: Randomized Trial

Resource links provided by NLM:


Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: August 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB) 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
Active Comparator: Drug Eluting Stent (DES) 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166711

Locations
Poland
Upper Silesian Heart Center
Katowice, Poland, 40-635
Sponsors and Collaborators
Aesculap AG
Investigators
Principal Investigator: Paweł E. Buszman, MD, PhD American Heart of Poland, Katowice
  More Information

No publications provided

Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT01166711     History of Changes
Other Study ID Numbers: SEQUENT 1000
Study First Received: July 20, 2010
Last Updated: October 15, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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

ClinicalTrials.gov processed this record on April 17, 2014