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

NCT00895791 | Withdrawn

• 1 other identifier: Eudract: 2009-010879-24
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Stenosis

Keywords

coronary bifurcation; stent implantation; PCI; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

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

  9 months

Secondary Outcomes (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.

  5 years

Study Arms (2)

1

ACTIVE COMPARATOR

AXXESS Biolimus A9-eluting bifurcation stent

Device: AXXESS Biolimus A9-eluting bifurcation stent

2

ACTIVE COMPARATOR

culotte stenting with use of 2 drug eluting stents

Device: culotte stenting (Xience V)

Interventions

AXXESS Biolimus A9-eluting bifurcation stent DEVICE

implantation of stent

1

culotte stenting (Xience V) DEVICE

implantation of stent

Also known as: culotte stenting with Xience V

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven Cardiology

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Tom Adriaenssens, MD

  UZLeuven, cardiology

  PRINCIPAL INVESTIGATOR

• Walter Desmet, MD, PhD

  UZ Leuven, Cardiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 8, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2015
• Last Updated: January 27, 2023

Record last verified: 2009-05

Locations

BE (1)