Comparative Response to Vascular Injury in Patients With Diabetes Mellitus: An OCT Study of BVS Versus Xience DES

October 18, 2017 updated by: Ottawa Heart Institute Research Corporation
Stents are used at centers around the world to unblock the arteries of the heart. These stents are usually made of metal and remain permanently within the blood vessel wall. Newer developments in the stent technology has led to stent scaffolds that can be reabsorbed over time. Patients with diabetes are prone to more complex blockages in the heart arteries which can be more difficult to treat. The purpose of this study is to compare the difference of how arteries heal early when metal stents or resorbable stents are used in patients with diabetes.

Study Overview

Status

Status

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Withdrawn

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

Coronary revascularization by percutaneous coronary intervention (PCI) is the dominant strategy in patients with obstructive coronary artery disease (CAD). Traditionally, PCI is performed with implantation of one or more permanent metallic stents which act as a scaffold for arterial recoil and, in the case of drug eluting stents (DES), provide a platform for delivery of anti-proliferative agents. A recent innovation in coronary stent technology is the advent of a bioresorbable vascular scaffold (BVS) - a poly L-lactide (PLLA) scaffold covered with a poly D,L-lactide coating which elutes everolimus. Bioresorption occurs by de-esterification of the long chains of PLLA into small particles which are then phagocytosed by macrophages. Within two years, the BVS is completely resorbed and vasomotor reactivity of the blood vessel is restored.

Patients with diabetes mellitus (DM) represent a clinically challenging population - having an increased incidence of complex CAD as well as higher rates of stent thrombosis (ST) and in-stent restenosis (ISR) following PCI. ST occurs most frequently in the first thirty days following stent implantation and is prevented by effective antiplatelet medications, optimization of stent deployment and by rapid reendothelialization (RE) of the device. Notably, patients with DM have delayed RE following stent implantation which results in a marked increase in risk of ST. Thus, patients with DM in particular are in need of devices that result in rapid establishment of stent coverage by optimizing the response to vascular injury.

Our study aims to answer the question: "Are there important differences in early healing between BVS and DES in patients with DM?" Our study hypothesis is that a BVS platform will enhance vascular healing resulting in greater strut coverage by 6 weeks in patients with DM.

This is a single centre, interventional, prospective cohort study which will be conducted between July 2017 and July 2019. A total of 52 patients will be recruited for participation in this study. Stable patients with diabetes will undergo randomization to either BVS or DES in the first target lesion using optical coherence tomography (OCT) at the time of the index procedure. Subsequently, patients will undergo staged PCI at four or six weeks (sub-randomization) of the second lesion with OCT evaluation of the initially implanted device to determine the percent of uncovered struts.

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

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

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:

  1. Stable patients with diabetes mellitus
  2. Two or more stenoses in a major epicardial native coronary artery
  3. An indication for PCI (i.e. >70% on angiography or fractional flow reserve (FFR) <0.8)
  4. Coronary anatomy suitable for a BVS

Exclusion Criteria:

  1. Unwillingness or inability to provide informed consent.
  2. ST-elevation myocardial infarction
  3. Hemodynamic instability

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

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.
ACTIVE_COMPARATOR: Xience Drug Eluting Stent
Patients with diabetes mellitus will be randomized to receive either a Xience drug eluting stent or an ABSORB bioresorbable vascular scaffold for treatment of obstructive coronary artery disease
Device: Xience Drug Eluting Stent
Patients will undergo insertion of a drug eluting stent with assessment of strut coverage using optical coherence tomography at 4 to 6 weeks after implantation.
ACTIVE_COMPARATOR: ABSORB Bioresorbable Vascular Scaffold
Patients with diabetes mellitus will be randomized to receive either a Xience drug eluting stent or an ABSORB bioresorbable vascular scaffold for treatment of obstructive coronary artery diseasee
Device: ABSORB Bioresorbable Vascular Scaffold
Patients will undergo insertion of a bioresorbable vascular scaffold with assessment of strut coverage using optical coherence tomography at 4 to 6 weeks after implantation.

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
Measure Description
Time Frame
Percentage of uncovered struts at time of follow-up optical coherence tomography
Time Frame: 4 to 6 weeks
The primary outcome will be the percent of uncovered struts analyzed at 5mm segments using a standardized protocol for optical coherence tomography at time of staged percutaneous coronary intervention procedure
4 to 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Late lumen loss
Time Frame: 4 to 6 weeks
Assessment of standardized lumen area at 5mm increments
4 to 6 weeks
Neointimal area:artery area
Time Frame: 4 to 6 weeks
Assessment of standardized neointimal area:artery area at 5mm increments
4 to 6 weeks
Strut malapposition
Time Frame: 4 to 6 weeks
Assessment of strut malapposition as a percentage of total struts
4 to 6 weeks
In-stent restenosis
Time Frame: 4 to 6 weeks
Binary in-stent restenosis defined as greater than 50% in-stent lumen loss
4 to 6 weeks
Target lesion revascularization
Time Frame: 4 to 6 weeks
Any intervention within 5mm of the study device
4 to 6 weeks
Major adverse cardiac events
Time Frame: 4 to 6 weeks
A composite of death, myocardial infarction or stroke
4 to 6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subgroup analysis between 4 and 6 weeks
Time Frame: 4 to 6 weeks
A subgroup analysis between four and six weeks will be performed to study the gradation of intimal response during early vascular healing
4 to 6 weeks

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.
Ottawa Heart Institute Research Corporation

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 (ANTICIPATED)

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.
August 1, 2017

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.
July 1, 2019

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.
July 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).
June 19, 2017

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.
July 31, 2017

First Posted (ACTUAL)

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.
August 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

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 19, 2017

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 18, 2017

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.
August 1, 2017

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.
  • 20170128-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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