DISsection RE-entry Evaluation With Absorb Bioresorbable Vascular Scaffolds in CTO. (DISCRETE-CTO)

Belfast Health and Social Care Trust

Status

Unknown

Conditions

Coronary Artery Disease

Treatments

Device: CTO PCI using Absorb Bioresorbable Vascular Scaffolds

Study type

Interventional

Funder types

Other

Identifiers

NCT02936011

15094SW-AS

Details and patient eligibility

About

Percutaneous Coronary Intervention (PCI) is increasingly effective to treat Chronic Total Occlusion (CTO) lesions in coronary arteries. This trial will examine modern dissection and re-entry approaches to treat more complex CTO lesions with the Absorb Bioresorbable Vascular Scaffold (BVS).

Full description

This is a pilot study, with the aim of hypothesis generation. This research aims to establish the feasibility and safety of treating chronic total occlusions using dissection and re-entry techniques in combination with everolimus-eluting bioresorbable vascular scaffolds (Absorb BVS).

Primary aims of the study are:

To demonstrate a low rate of Target Vessel Failure (stent thrombosis, restenosis or late closure) at 12 and 24 months after CTO PCI and stenting with the Absorb BVS
To demonstrate a high degree of endothelial stent strut coverage at 12 and 24 moths after CTO PCI and stenting with the Absorb BVSThe primary outcome measure is

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patient >18 years old with capacity to provide informed consent
Females of childbearing potential have a negative pregnancy test
Subject understands the trial requirements, the treatment procedures and provides written informed consent
Presence of Chronic Total Occlusion (CTO) in a main epicardial coronary vessel that is known or presumed to be of at least 3 months in duration
The CTO has been crossed using ADR or RDR techniques and subintimal wire passage is documented on IVUS
Target vessel is >2.5mm and <4mm in diameter and the lesion can the diseased segment can be covered with 3 Absorb BVS stents
Target lesion is fully prepared and dilatable before BVS insertion • Absorb BVS are successfully implanted in the target lesion

Exclusion criteria

Acute myocardial infarction with ongoing ST-elevation
Cardiogenic shock
Left ventricular ejection fraction <20%
Subject has one of the following (as assessed prior to the index procedure): - Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months; Current problems with substance abuse; There is a planned non-cardiac procedure that may cause non-compliance with the protocol or confound data interpretation
Subject will has a condition meaning they are unlikely to tolerate dual antiplatelet therapy for 12 months Subject is treated by dialysis or has a baseline serum creatinine level >220 μmol/L (2.5 mg/dL)
Known allergy to to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g. Everolimus or PLLA polymer, all P2Y12 inhibitors, or aspirin)
Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint OR subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
Need for ongoing long-term anticoagulation
Subject has received an organ transplant or is on a waiting list for an organ transplant •Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months
Presence of a stent occlusion or the subject was previously treated at any time with intravascular brachytherapy
Subject has a clinically significant bleeding diathesis or coagulopathy or will refuse blood transfusions
Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months