Clinical Trials Logo
  1. Home
  2. Coronary Artery Stenosis
  3. NCT00895791

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

Coronary Artery Stenosis Clinical Trial

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.

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00895791
Study type Interventional
Source Universitaire Ziekenhuizen KU Leuven
Contact
Status Withdrawn
Phase N/A
Start date June 2009
Completion date December 2015
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05133843 - Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis N/A
Completed NCT01205776 - EXCEL Clinical Trial N/A
Completed NCT01182428 - XIENCE V: SPIRIT WOMEN Sub-study Phase 4
Completed NCT00739466 - Biorest Liposomal Alendronate With Stenting sTudy (BLAST) Phase 2
Completed NCT01332591 - Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy. N/A
Completed NCT01310309 - EXecutive Registry: Evaluating XIENCE V® in a Multi Vessel Disease Phase 4
Completed NCT00531011 - EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease Phase 4
Not yet recruiting NCT06052670 - Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Coronary Artery Lesions
Completed NCT05509296 - Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease N/A
Not yet recruiting NCT05393882 - Impact of Cholesterol Level on Long-term Coronary Bypass Graft Patency
Recruiting NCT06397820 - Relation Between AI-QCA and Cardiac PET
Active, not recruiting NCT01960504 - First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II) N/A
Completed NCT01721096 - XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
Active, not recruiting NCT01342822 - Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization Phase 4
Completed NCT01205789 - EXCEL Clinical Trial (Universal Registry) N/A
Recruiting NCT05532605 - Effects of Mindfulness Based Therapy on Illness and Depression in Cardiac Rehab Phase-i N/A
Completed NCT02066623 - Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold
Not yet recruiting NCT02946320 - Optimal Predilatation Technique for BVS Implantation Phase 3
Completed NCT01249027 - XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
Completed NCT01136876 - Kidney Damage in Patients With Moderate Fall in eGFR Phase 4