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

NCT03236415 | Withdrawn FDA Device

• 1 other identifier: 20170128-01H
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Percentage of uncovered struts at time of follow-up optical coherence tomography

  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 Outcomes (6)

• Late lumen loss

  4 to 6 weeks

• Neointimal area:artery area

  4 to 6 weeks

• Strut malapposition

  4 to 6 weeks

• In-stent restenosis

  4 to 6 weeks

• Target lesion revascularization

  4 to 6 weeks

Other Outcomes (1)

• Subgroup analysis between 4 and 6 weeks

  4 to 6 weeks

Study Arms (2)

Xience Drug Eluting Stent

ACTIVE COMPARATOR

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

ABSORB Bioresorbable Vascular Scaffold

ACTIVE COMPARATOR

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

Interventions

Xience Drug Eluting Stent DEVICE

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.

Xience Drug Eluting Stent

ABSORB Bioresorbable Vascular Scaffold DEVICE

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.

ABSORB Bioresorbable Vascular Scaffold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unwillingness or inability to provide informed consent.
• ST-elevation myocardial infarction
• Hemodynamic instability

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Benjamin Hibbert, MD PhD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: August 1, 2017
• Study Start: August 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 19, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share