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PCI With AXXESS Biolimus A9 Eluting Bifurcation Stent in Treating Coronary Artery Bifurcation Disease

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ClinicalTrials.gov Identifier: NCT02384629
Recruitment Status : Withdrawn (Problem with medical device provider)
First Posted : March 10, 2015
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
  1. To compare the safety and efficacy of AXXESS stent with conventional DES in patients with coronary artery bifurcation disease
  2. To assess the impact of optical coherence tomography (OCT) guidance on clinical outcomes following the stent type

Condition or disease Intervention/treatment Phase
Coronary Bifurcation Lesions Device: OCT-guided PCI with AXXESS stent Device: OCT-guided PCI with conventional DES (Biomatrix flex stent) Device: Angio-guided PCI with AXXESS stent Device: Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PCI With AXXESS Biolimus A9 Eluting Bifurcation Stent in Treating Coronary Artery Bifurcation Disease
Study Start Date : March 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Umirolimus

Arm Intervention/treatment
Experimental: AXXESS stent1
AXXESS stent (OCT-guided)
Device: OCT-guided PCI with AXXESS stent
The AXXESS stent (Biosensors Europe SA, Morges, Switzerland) is a dedicated self-expanding bifurcation stent eluting the sirolimus analog Biolimus A9 emulsed in a biodegradable polymer. It has the advantage to preserve the ostium of both distal branches and allows additional stent implantation in the distal branches for complete lesion coverage, while reducing large stent overlap and eliminating deformation. Optical coherence tomography (OCT), has enabled the evaluation of strut coverage and arterial healing after DES implantation with a superior resolution and delineation over other imaging modalities. With using these superiorities of OCT, there have been many studies assessing the neointimal coverage following various types of DES implantation in various periods.

Experimental: Conventional DES1
Conventional DES (Biomatrix flex stent, OCT-guided)
Device: OCT-guided PCI with conventional DES (Biomatrix flex stent)
BioMatrix Flex is abluminal biodegradable polymer DES. Its abluminal coating is absorbed after 6 to 9months and turns the DES into a BMS. It combines the proven safety of a DES with an abluminal biodegradable polymer, the prove efficacy of BA9 and an advanced stent design. Optical coherence tomography (OCT), has enabled the evaluation of strut coverage and arterial healing after DES implantation with a superior resolution and delineation over other imaging modalities. With using these superiorities of OCT, there have been many studies assessing the neointimal coverage following various types of DES implantation in various periods.

Active Comparator: AXXESS stent2
AXXESS stent (Angio-guided)
Device: Angio-guided PCI with AXXESS stent
The AXXESS stent (Biosensors Europe SA, Morges, Switzerland) is a dedicated self-expanding bifurcation stent eluting the sirolimus analog Biolimus A9 emulsed in a biodegradable polymer. It has the advantage to preserve the ostium of both distal branches and allows additional stent implantation in the distal branches for complete lesion coverage, while reducing large stent overlap and eliminating deformation. We use the conventional coronary angiography.

Active Comparator: Conventional DES2
Conventional DES (Biomatrix flex stent, Angio-guided)
Device: Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent)
BioMatrix Flex is abluminal biodegradable polymer DES. Its abluminal coating is absorbed after 6 to 9months and turns the DES into a BMS. It combines the proven safety of a DES with an abluminal biodegradable polymer, the prove efficacy of BA9 and an advanced stent design. We use the conventional coronary angiography.




Primary Outcome Measures :
  1. Late loss of side branch(SB) [ Time Frame: 9 months after procedure ]
    Late loss was defined as the difference between the minimal luminal diameter (MLD) immediately after the procedure and the MLD at 9-month follow-up, Measured the change in MLD by Quantitative coronary angiography (QCA)


Secondary Outcome Measures :
  1. Cardiovascular (CV) death [ Time Frame: 9 months after procedure ]
    death for CV cause (MI, stroke)

  2. Myocardial infarction (MI) [ Time Frame: 9 months after procedure ]
    MI definition: rise of cardiac biomarker with at least one of the following: Symptoms of ischemia, New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB), Development of pathological Q waves in the ECG, Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality, identification of an intracoronary thrombus by angiography or autopsy

  3. stent thrombosis (ST) [ Time Frame: 9 months after procedure ]
    ST definition: Academic Research Consortium (ARC) definition

  4. SB closure [ Time Frame: 9 months after procedure ]
    SB closure: TIMI flow < 3 and/or stenosis >75%



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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures,
  • Patients ≥ 19 years old,
  • Patients who are expected to undergo PCI for bifurcation lesions.

Exclusion Criteria:

  • Age> 85 years,
  • Cardiogenic shock or unstable patients,
  • Increased risk of bleeding, anemia, thrombocytopenia,
  • A need for oral anticoagulation therapy,
  • Pregnant women or women with potential childbearing,
  • Life expectancy < 1 year.

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02384629     History of Changes
Other Study ID Numbers: 1-2014-0079
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Sirolimus
Umirolimus
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents