Overview

This trial is active, not recruiting.

Condition true coronary bifurcation lesions
Treatments axxess + biomatrix biolimus eluting stent, culotte technique with xience v or xience prime stents
Phase phase 4
Sponsor Universitaire Ziekenhuizen Leuven
Collaborator Biosensors International
Start date November 2011
End date December 2013
Trial size 40 participants
Trial identifier NCT01486095, UH Leuven S53441

Summary

Treatment of bifurcation lesions with drug-eluting stents (DES) (especially when a double stent technique is used) is associated with a higher risk for stent thrombosis. Different factors may play a role in the higher risk for stent thrombosis in bifurcation lesions. Possible mechanisms are delayed endothelialisation due to the action of the drug, coating polymers, or overlapping stent segments, incomplete stent apposition at specific sites in the bifurcation lesion and higher thrombogenicity due to turbulent flow at the bifurcation site. In human pathological data, the RUTSS (ratio of uncovered to total stent struts) appears to be the most powerful predictor of stent thrombosis.

This prospective study will assess the differences in stent strut coverage and stent strut apposition after complex bifurcation lesion treatment with the dedicated AXXESS Biolimus A9-eluting bifurcation stent at the bifurcation site and additional Biomatrix Biolimus A9-eluting stents in the distal main vessel and the side branch versus treatment with the culotte technique using the Xience Prime everolimus-eluting stents.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
After mandatory predilatation, a self-expanding, conically shaped nickel-titanium AXXESS biolimus A9-eluting stent is placed at the level of the carina. The device is available in 3.0 and 3.5 mm calibre and 11 and 14 mm length. Depending on the lesion anatomy, additional Biomatrix™ Drug Eluting Coronary Stent Systems are placed distally if necessary. The procedure is completed with kissing balloon postdilatation using non-compliant balloons sized to the reference vessel diameter of the distal branches. Before this kissing balloon inflation, consecutive high pressure inflations should be performed in both branches.
axxess + biomatrix biolimus eluting stent
NAP
(Active Comparator)
The culotte technique consists of stenting one of both branches of the bifurcation lesion first, and after balloon dilatation of the stent meshes, stenting the uncovered branch through the first stent and leaving the main vessel covered with two overlapped stents. The procedure is terminated by kissing balloon dilatation of both branches using non-compliant balloons sized to the reference vessel diameter of the distal branches. Before this kissing balloon inflation, consecutive high pressure inflations should be performed in both branches.
culotte technique with xience v or xience prime stents
NAP

Primary Outcomes

Measure
Primary endpoint
time frame: 9 months

Secondary Outcomes

Measure
Secondary endpoint : stent strut coverage per segment with OCT
time frame: 9 months
Secondary endpoint: stent strut apposition with OCT
time frame: 9 months
Secondary endpoint: clusters of malapposition with OCT
time frame: 9 months
Secondary endpoint: Tissue strut thickness with OCT
time frame: 9 months
Secondary endpoint: neointimal hyperplasia volume
time frame: 9 months
Secondary endpoint: late luminal loss (angiography)
time frame: 9 months
Secondary endpoint: in-segment late luminal loss (angiography)
time frame: 9 months
Secondary endpoint: binary restenosis (angiography)
time frame: 9 months
Secondary endpoint: binary in-segment restenosis (angiography)
time frame: 9 months
Secondary endpoint: minimal lumen diameter (angiography)
time frame: 9 months
Secondary endpoints: clinical: MACE
time frame: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoints: clinical: components of MACE: cardiac death
time frame: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoints: clinical: components of MACE: Q- or non-Q-wave myocardial infarction
time frame: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoints: clinical: components of MACE: clinically driven target lesion revascularization (TLR)
time frame: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoint: Stent thrombosis
time frame: 24h, 1 month, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: Target vessel revascularization
time frame: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: all-cause death
time frame: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: non-target revascularization
time frame: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: any coronary revascularization
time frame: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: device success
time frame: Immediately after initial treatment of the study lesion
Secondary endpoint: lesion treatment success
time frame: Immediately after initial treatment of the study lesion
Secondary endpoint: procedure success
time frame: 24h after treatment of the target lesion

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patient older than 18 years 2. The subject has stable or unstable angina pectoris, or a positive functional study for ischemia. 3. The subject is eligible for PCI, and is an acceptable candidate for coronary artery bypass surgery. 4. The subject is male, or if female, has no childbearing potential or has had a negative urine or serum pregnancy test within 7 days of the index procedure and has no intention to become pregnant within a year of the procedure. 5. The subject has signed the informed consent prior to the procedure, and agrees to comply with the follow up requirements. 6. Patients with a de novo and true coronary bifurcation lesion (Medina classification (1,1,1), (1,0,1) or (0,1,1)). 7. Coronary artery with proximal parent vessel reference diameter of 2.75 - 3.75 mm and a branch vessel diameter of ≥ 2.25 mm. 8. The lesion must be at least 50% diameter stenosis within either the MB or SB. 9. Regarding lesion length: lesion should be able to be covered by 2 Xience Prime stents in a Culotte technique, or by a combination of maximally 1 AXXESS and 2 Biomatrix™ Drug Eluting Coronary Stents. 10. The side branch ostium is located at least 12 mm from the left main coronary artery. 11. The angle between the sidebranch and the parent vessel is less than 70°. 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. The target vessel contains intraluminal thrombus. 6. The target lesion shows angiographic evidence of moderate to severe calcification or tortuosity. 7. Known allergies to antiplatelet, anticoagulation therapy, contrast media, everolimus or biolimus, stainless steel, cobalt, chromium, nickel or titanium 8. Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required) 9. Patients with a life expectancy of less than one year 10. Patient currently enrolled in other investigational device or drug trial 11. Patient not able or willing to adhere to follow-up visits 12. Patients who intend to have a major surgical intervention within 6 months of enrolment in the study. 13. Patients who previously participated in this study.

Additional Information

Official title Comparison of Healing Responses After Treatment of Complex Bifurcation Lesions With a Dedicated Bifurcation Device (Axxess™ Drug Eluting Coronary Bifurcation Stent System + Biomatrix™ Drug Eluting Coronary Stent System Stents in the Distal Branches) Versus the Culotte Technique Using Xience Prime Everolimus-eluting Stents : an Optical Coherence Tomography (OCT) Analysis
Principal investigator Christophe L Dubois, MD, PhD
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. AIMS: 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-endothelialisation and quality of strut apposition to the vessel wall. METHODS: Patients with true bifurcation lesions with involvement of a significant side branch requiring a stent will be randomly assigned to one of two treatment strategies. Group A will comprise 20 patients which will be treated with the Axxess™ Drug Eluting Coronary Bifurcation Stent System (Biosensors Europe SA) where additional Biomatrix™ Drug Eluting Coronary Stent Systems (Biosensors Europe SA) are implanted into the distal main branch (MB) and the side branch (SB) as required. Group B will consist of 20 patients which will be treated with the culotte technique using Xience Prime everolimus-eluting stents (Abbott-Vascular, US). Kissing balloon dilatation using non-compliant balloons will complete the index procedure in all cases. At 9 months, control angiography for all patients (with QCA using dedicated software) and OCT (of both main vessel and side branch) will be performed. ENROLMENT PLAN: Start: Third quarter of 2011 Enrolment period: ± 12 months Clinical follow-up: 5 years Angiographic and OCT results expected third quarter of 2013
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.