Status:
UNKNOWN
COmplex BifuRcation Lesions: a Comparison Between the AXXESS Device and Culotte Stenting: an Optical Coherence Tomography (OCT) Study
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Biosensors International
Conditions:
True Coronary Bifurcation Lesions
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 r...
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...
Eligibility Criteria
Inclusion
- Patient older than 18 years
- The subject has stable or unstable angina pectoris, or a positive functional study for ischemia.
- The subject is eligible for PCI, and is an acceptable candidate for coronary artery bypass surgery.
- 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.
- The subject has signed the informed consent prior to the procedure, and agrees to comply with the follow up requirements.
- Patients with a de novo and true coronary bifurcation lesion (Medina classification (1,1,1), (1,0,1) or (0,1,1)).
- Coronary artery with proximal parent vessel reference diameter of 2.75 - 3.75 mm and a branch vessel diameter of ≥ 2.25 mm.
- The lesion must be at least 50% diameter stenosis within either the MB or SB.
- 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.
- The side branch ostium is located at least 12 mm from the left main coronary artery.
- The angle between the sidebranch and the parent vessel is less than 70°.
Exclusion
- 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
- The target vessel contains intraluminal thrombus.
- The target lesion shows angiographic evidence of moderate to severe calcification or tortuosity.
- Known allergies to antiplatelet, anticoagulation therapy, contrast media, everolimus or biolimus, stainless steel, cobalt, chromium, nickel or titanium
- 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.
- Patients who previously participated in this study.
Key Trial Info
Start Date :
November 29 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01486095
Start Date
November 29 2011
End Date
December 1 2017
Last Update
May 9 2017
Active Locations (2)
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1
ZOL Genk
Genk, Belgium, 3600
2
UH Leuven
Leuven, Belgium, 3000