Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03236415
Recruitment Status : Withdrawn (Global sales of the Absorb BVS halted effective September 14, 2017.)
First Posted : August 1, 2017
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diabetes Mellitus Device: Xience Drug Eluting Stent Device: ABSORB Bioresorbable Vascular Scaffold Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Response to Vascular Injury in Patients With Diabetes Mellitus: An OCT Study of BVS Versus Xience DES
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Late lumen loss [ Time Frame: 4 to 6 weeks ]
    Assessment of standardized lumen area at 5mm increments

  2. Neointimal area:artery area [ Time Frame: 4 to 6 weeks ]
    Assessment of standardized neointimal area:artery area at 5mm increments

  3. Strut malapposition [ Time Frame: 4 to 6 weeks ]
    Assessment of strut malapposition as a percentage of total struts

  4. In-stent restenosis [ Time Frame: 4 to 6 weeks ]
    Binary in-stent restenosis defined as greater than 50% in-stent lumen loss

  5. Target lesion revascularization [ Time Frame: 4 to 6 weeks ]
    Any intervention within 5mm of the study device

  6. Major adverse cardiac events [ Time Frame: 4 to 6 weeks ]
    A composite of death, myocardial infarction or stroke


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236415


Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Layout table for investigator information
Principal Investigator: Benjamin Hibbert, MD PhD Ottawa Heart Institute Research Corporation

Layout table for additonal information
Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT03236415     History of Changes
Other Study ID Numbers: 20170128-01H
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Vascular System Injuries
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Wounds and Injuries