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

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ClinicalTrials.gov Identifier: NCT00895791
Recruitment Status : Unknown
Verified May 2009 by University Hospital, Gasthuisberg.
Recruitment status was:  Not yet recruiting
First Posted : May 8, 2009
Last Update Posted : May 8, 2009
Information provided by:

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.

Condition or disease Intervention/treatment
Coronary Artery Stenosis Device: AXXESS Biolimus A9-eluting bifurcation stent Device: culotte stenting (Xience V)

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:

  1. EP: stent strut coverage and stent strut apposition, assessed with OCT at 9 months.
  2. EP: restenosis, restenosis at SB ostium, MACE, stent thrombosis.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2015
Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
AXXESS Biolimus A9-eluting bifurcation stent
Device: AXXESS Biolimus A9-eluting bifurcation stent
implantation of stent
Active Comparator: 2
culotte stenting with use of 2 drug eluting stents
Device: culotte stenting (Xience V)
implantation of stent
Other Name: culotte stenting with Xience V

Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895791

Contact: Tom Adriaenssens, MD +3216342464 Tom.Adriaenssens@uzleuven.be
Contact: Christophe Dubois, MD +3216342464 Christophe.Dubois@uzleuven.be

UZ Leuven Cardiology Not yet recruiting
Leuven, Belgium, 3000
Contact: Tom Adriaenssens, MD         
Sub-Investigator: Christophe Dubois, MD         
Principal Investigator: Tom Adriaenssens, MD         
Sub-Investigator: Walter Desmet, MD, PhD         
Sponsors and Collaborators
University Hospital, Gasthuisberg
Principal Investigator: Tom Adriaenssens, MD UZLeuven, cardiology
Study Director: Walter Desmet, MD, PhD UZ Leuven, Cardiology
More Information

Responsible Party: dr. Tom Adriaenssens, UZ Leuven, cardiology
ClinicalTrials.gov Identifier: NCT00895791     History of Changes
Other Study ID Numbers: Eudract: 2009-010879-24
First Posted: May 8, 2009    Key Record Dates
Last Update Posted: May 8, 2009
Last Verified: May 2009

Keywords provided by University Hospital, Gasthuisberg:
coronary bifurcation
stent implantation
Optical Coherence Tomography

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents