COmplex Bifurcation PCI: AXXESS Device + Absorb BVS, vs Modified T Stenting With Absorb BVS

NCT02628288 | Unknown

• 1 other identifier: S-57892
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of healing responses after treatment of complex bifurcation lesions with a dedicated bifurcation device (Axxess™ Biolimus Eluting Coronary Bifurcation Stent System + Absorb BVS in the distal branches) versus the Modified T stenting technique using Absorb BVS: an optical coherence tomography (OCT) analysis.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Changes in minimal luminal area in 4 pre-specified bifurcation segments (Proximal mainbranch (MB) segment; Bifurcation segment; Ostial distal MB segment; Ostial side-branch (SB segment), assessed with OCT, from baseline to 30 months.

  30 months

Secondary Outcomes (26)

• Acute strut apposition following index PCI (baseline OCT)

  30 months

• Cumulative major adverse cardiac events (MACE) rate (cardiac death, myocardial infarction, clinically driven TLR) at 1, 6 and 12 months and annually for 5 years from the procedure date.

  1 month, 6 months, 1,2,3,4,5 years

• Quantitative coronary angiography (QCA) Minimal Lumen Diameter before and after PCI, and at 30 months

  24 hours and at 30 months

• Device success, defined as deployment of the assigned stents without system failure or device-related complication

  24 hours

• Presence of thrombus on final OCT pullback following index PCI

  24 hours

Study Arms (2)

PCI with Axxess device + AbsorB BVS

ACTIVE COMPARATOR

Bifurcation lesion will be treated percutaneously by performing coronary stenting with AXXESS device and additional Absorb BVS.

Device: Coronary Bifurcation PCI

PCI with Modified T with Absorb BVS

ACTIVE COMPARATOR

Bifurcation lesion will be treated percutaneously by performing coronary stenting with a modified T stenting technique using Absorb BVS.

Device: Coronary Bifurcation PCI

Interventions

Coronary Bifurcation PCI DEVICE

In one group, the coronary bifurcation lesion will be treated (Coronary bifurcation PCI) with the Axxess device + Absorb BVS. In the other group, the coronary bifurcation lesions will be treated(Coronary bifurcation PCI) by modified T stenting using Absorb BVS.

PCI with Axxess device + AbsorB BVS; PCI with Modified T with Absorb BVS

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
• 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)) or any other anatomical presentation requiring a double stent technique by judgment of the operator.
• Coronary artery with proximal parent vessel reference diameter of 2.75 - 3.75 mm and a branch vessel diameter of ≥ 2.25 mm (by visual estimate).
• The lesion must be at least 50% diameter stenosis within either the MB or SB (by visual estimate).
• Regarding lesion length: lesion should be able to be covered by 2 Absorb BVS in a Modified T-stenting technique, or by a combination of maximally 1 AXXESS and 2 Absorb BVS (by visual estimate).
• The side branch ostium is located at least 10 mm from the left main coronary artery (by visual estimate).
• The angle between the sidebranch and the parent vessel is less than 70°(by visual estimate).

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
• Known allergies to antiplatelet, anticoagulation therapy, contrast media, biolimus or everolimus, nickel, titanium or poly-D,L-lactic Acid.
• Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
• Patients with a life expectancy of less than three years
• Patient currently enrolled in other investigational device or drug trial of which the primary endpoint timing has not been reached and potentially interferes with the outcome of either of both trials
• Patient not able or willing to adhere to follow-up visits
• Patients who intend to have a major surgical intervention within 12 months of enrolment in the study.
• Patients who previously participated in this study.
• Subject has experienced an acute myocardial infarction 72 hours prior to the index procedure, as defined either by the presence of a new Q-wave in 2 or more contiguous leads, or by a CK greater than two times site upper reference limit (URL) with presence of creatine Kinase-MB ( CKMB) greater than the site URL.
• Creatinine Kinase (CK) greater than two times URL with presence of CKMB greater than the site URL at the time of procedure.
• The subject has suffered a stroke or transient ischemic neurological attack or cerebrovascular accident within the past six months, or has any known intracranial mass, arteriovenous malformation, aneurysm or other intracranial pathology
• The subject has experienced a significant gastrointestinal or genitourinary bleed within the past six months, or has had any active bleeding within two months.
• The subject is taking warfarin or NOAC, will need to take warfarin or novel oral anticoagulants (NOAC) post procedure, or has an international normalised ratio (INR) \> 1.4.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Department of Cardiovascular Disease, University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Johan Bennett, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Bennett, MD

CONTACT

johan.bennett@uzleuven.be

Christophe Dubois, MD PhD

CONTACT

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: November 17, 2015
• First Posted: December 11, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: November 1, 2020
• Last Updated: December 11, 2015

Record last verified: 2015-11

Locations

BE (1)