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COmplex BifuRcation Lesions: A Comparison Between the AXXESS Device and Culotte Stenting: An Optical Coherence Tomography (OCT) Study (COBRA)

Primary Purpose

Coronary Artery Stenosis

Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
AXXESS Biolimus A9-eluting bifurcation stent
culotte stenting (Xience V)
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Stenosis focused on measuring coronary bifurcation, stent implantation, PCI, Optical Coherence Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient older than 18 years
  2. Written informed consent available
  3. Patient eligible for percutaneous coronary intervention
  4. Patients with a de novo and true coronary bifurcation lesion (Medina classification (1,1,1), (1,0,1) or (0,1,1))
  5. Target reference vessel diameter measured by QCA: 2-4 mm
  6. Target lesion stenosis measured by QCA: > 70% - < 100%
  7. Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations

Exclusion Criteria:

  1. Left ventricular ejection fraction of < 30%
  2. Impaired renal function (serum creatinine > 2.0 mg/dl)
  3. Previous and/or planned brachytherapy of target vessel
  4. Lesion of the left main trunk > 50%, unprotected
  5. Known allergies to antiplatelet, anticoagulation therapy, contrast media or everolimus
  6. Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
  7. Patients with a life expectancy of less than one year
  8. Patient currently enrolled in other investigational device or drug trial
  9. Patient not able or willing to adhere to follow-up visits
  10. Patients who intend to have a major surgical intervention within 6 months of enrolment in the study
  11. Patient not able or willing to adhere to follow-up visits
  12. Patients who previously participated in this study

Sites / Locations

  • UZ Leuven Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

AXXESS Biolimus A9-eluting bifurcation stent

culotte stenting with use of 2 drug eluting stents

Outcomes

Primary Outcome Measures

The primary endpoint is % stent strut coverage and % stent strut apposition, assessed with optical coherence tomography, at 9 months follow-up.

Secondary Outcome Measures

Clinical outcome: Cumulative MACE rate at 1, 8, 9 and 12 months, yearly until 5 years. Separate rates will be provided for: cardiac death, non-fatal myocardial infarction, clinically driven TLR, TVR.

Full Information

First Posted
May 7, 2009
Last Updated
January 26, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT00895791
Brief Title
COmplex BifuRcation Lesions: A Comparison Between the AXXESS Device and Culotte Stenting: An Optical Coherence Tomography (OCT) Study
Acronym
COBRA
Official Title
Comparison of Healing Responses After Treatment of Complex Bifurcation Lesions With the AXXESS Biolimus A9 Eluting Stent Versus Culotte Technique Using Everolimus-eluting Stents: an Optical Coherence Tomography Analysis.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Withdrawn
Why Stopped
major protocol changes: new study submitted
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

5. Study Description

Brief Summary
The aim of this study is to compare vessel healing at 9 months using OCT imaging for two different treatment techniques for treating bifurcation lesions. Quantitative assessment of OCT images will be used to assess re-endothelialization and quality of strut apposition to the vessel wall.
Detailed Description
Background: There is an ongoing controversy over the efficacy and safety of different bifurcation stenting techniques. Critical considerations are the rate of restenosis at the side branch ostium, and completeness of healing at sites of overlap of stent struts, which may affect the risk of stent thrombosis. Methods: Patients with complex bifurcation lesions with involvement of a significant side branch requiring a stent are randomized into two treatment arms. The first group of 20 patients (group I) is treated with the AXXESS Biolimus A9 Bifurcation Stent System (Devax, Inc, Lake Forest CA), where additional everolimus-eluting Xience V stents (Abbott Vascular, Santa Clara, CA) are implanted into the distal main branch and the side branch as required. The second group of 20 patients (group II) is treated with the culotte technique using everolimus-eluting Xience V stents. Kissing balloon dilatation using non-compliant balloons will complete the index procedure in all cases. At 9 months, control angiography (with QCA using dedicated software) and OCT (of both main vessel and side branch) is performed. Assessment of Results: EP: stent strut coverage and stent strut apposition, assessed with OCT at 9 months. EP: restenosis, restenosis at SB ostium, MACE, stent thrombosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis
Keywords
coronary bifurcation, stent implantation, PCI, Optical Coherence Tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
AXXESS Biolimus A9-eluting bifurcation stent
Arm Title
2
Arm Type
Active Comparator
Arm Description
culotte stenting with use of 2 drug eluting stents
Intervention Type
Device
Intervention Name(s)
AXXESS Biolimus A9-eluting bifurcation stent
Intervention Description
implantation of stent
Intervention Type
Device
Intervention Name(s)
culotte stenting (Xience V)
Other Intervention Name(s)
culotte stenting with Xience V
Intervention Description
implantation of stent
Primary Outcome Measure Information:
Title
The primary endpoint is % stent strut coverage and % stent strut apposition, assessed with optical coherence tomography, at 9 months follow-up.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Clinical outcome: Cumulative MACE rate at 1, 8, 9 and 12 months, yearly until 5 years. Separate rates will be provided for: cardiac death, non-fatal myocardial infarction, clinically driven TLR, TVR.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient older than 18 years Written informed consent available Patient eligible for percutaneous coronary intervention Patients with a de novo and true coronary bifurcation lesion (Medina classification (1,1,1), (1,0,1) or (0,1,1)) Target reference vessel diameter measured by QCA: 2-4 mm Target lesion stenosis measured by QCA: > 70% - < 100% Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations Exclusion Criteria: Left ventricular ejection fraction of < 30% Impaired renal function (serum creatinine > 2.0 mg/dl) Previous and/or planned brachytherapy of target vessel Lesion of the left main trunk > 50%, unprotected Known allergies to antiplatelet, anticoagulation therapy, contrast media or everolimus Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required) Patients with a life expectancy of less than one year Patient currently enrolled in other investigational device or drug trial Patient not able or willing to adhere to follow-up visits Patients who intend to have a major surgical intervention within 6 months of enrolment in the study Patient not able or willing to adhere to follow-up visits Patients who previously participated in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Adriaenssens, MD
Organizational Affiliation
UZLeuven, cardiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Walter Desmet, MD, PhD
Organizational Affiliation
UZ Leuven, Cardiology
Official's Role
Study Director
Facility Information:
Facility Name
UZ Leuven Cardiology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

COmplex BifuRcation Lesions: A Comparison Between the AXXESS Device and Culotte Stenting: An Optical Coherence Tomography (OCT) Study

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