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

NCT ID: NCT00895791

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Coronary Artery Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

AXXESS Biolimus A9-eluting bifurcation stent

Group Type: ACTIVE_COMPARATOR

AXXESS Biolimus A9-eluting bifurcation stent

Intervention Type: DEVICE

implantation of stent

2

culotte stenting with use of 2 drug eluting stents

Group Type: ACTIVE_COMPARATOR

culotte stenting (Xience V)

Intervention Type: DEVICE

implantation of stent

Interventions

AXXESS Biolimus A9-eluting bifurcation stent

implantation of stent

Intervention Type: DEVICE

culotte stenting (Xience V)

implantation of stent

Intervention Type: DEVICE

Other Intervention Names

culotte stenting with Xience V

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom Adriaenssens, MD

Role: PRINCIPAL_INVESTIGATOR

UZLeuven, cardiology

Walter Desmet, MD, PhD

Role: STUDY_DIRECTOR

UZ Leuven, Cardiology

Locations

UZ Leuven Cardiology

Leuven, , Belgium

Countries

Belgium

Other Identifiers

Eudract: 2009-010879-24

Identifier Type: -

Identifier Source: org_study_id