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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2009 by University Hospital, Gasthuisberg
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00895791
First received: May 7, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention
Coronary Artery Stenosis
Device: AXXESS Biolimus A9-eluting bifurcation stent
Device: culotte stenting (Xience V)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
AXXESS Biolimus A9-eluting bifurcation stent
Device: AXXESS Biolimus A9-eluting bifurcation stent
implantation of stent
Other Name: AXXESS Biolimus A9-eluting bifurcation 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

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.
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895791

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

Locations
Belgium
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
Investigators
Principal Investigator: Tom Adriaenssens, MD UZLeuven, cardiology
Study Director: Walter Desmet, MD, PhD UZ Leuven, Cardiology
  More Information

No publications provided

Responsible Party: dr. Tom Adriaenssens, UZ Leuven, cardiology
ClinicalTrials.gov Identifier: NCT00895791     History of Changes
Other Study ID Numbers: Eudract: 2009-010879-24
Study First Received: May 7, 2009
Last Updated: May 7, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

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

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 25, 2014