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
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Stenosis||Device: AXXESS Biolimus A9-eluting bifurcation stent Device: culotte stenting (Xience V)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
- 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 ]
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|
|Principal Investigator:||Tom Adriaenssens, MD||UZLeuven, cardiology|
|Study Director:||Walter Desmet, MD, PhD||UZ Leuven, Cardiology|