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

October 14, 2016 updated by: Belfast Health and Social Care Trust

DISsection RE-entry Evaluation With Absorb Bioresorbable Vascular Scaffolds in Chronic Total Occlusion. The DISCRETE CTO Study.

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CTO PCI with Absorb BVS
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
CTO PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belfast Health and Social Care Trust

Collaborators

Bristol Royal Infirmary
Royal Infirmary of Edinburgh
Golden Jubilee National Hospital

Investigators

  • Principal Investigator: Simon J Walsh, MD, Belfast Health and Social Care Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15094SW-AS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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