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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Belfast Health and Social Care Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol Royal Infirmary
Royal Infirmary of Edinburgh
Golden Jubilee National Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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