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

NCT02936011 | Unknown DMC

• 1 other identifier: 15094SW-AS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Target Vessel Failure as per ARC criteria (composite occurrence of any revascularization of the target lesion, myocardial infarction (MI) related to the target vessel, or cardiac death)

  12 months

Study Arms (1)

CTO PCI with Absorb BVS

OTHER

Single arm observational after successful CTO PCI with Absorb BVS after antegrade or retrograde dissection and re-entry

Device: CTO PCI using Absorb Bioresorbable Vascular Scaffolds

Interventions

CTO PCI using Absorb Bioresorbable Vascular Scaffolds DEVICE

CTO PCI

CTO PCI 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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• Bristol Royal Infirmary: collaborator
• Golden Jubilee National Hospital: collaborator
• Royal Infirmary of Edinburgh: collaborator

Study Sites (1)

Belfast Health & Social Care Trust

Belfast, BT12 6BA, United Kingdom

RECRUITING

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

• Simon J Walsh, MD

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Murphy

CONTACT

00442890636349; alison.murphy@belfasttrust.hscni.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 18, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2019
• Last Updated: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)