Optical Frequency Domain Imaging (OFDI) and Vascular Healing After Stent Placement

NCT01794949 | Completed Results DMC FDA Device

• 1 other identifier: IRB00057208
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The use of drug eluting stents (DES) used to treat coronary artery blockages is limited by poor healing of the stented area. This will require the combined use of blood thinners such as aspirin and clopidogrel (i.e. dual anti-platelet therapy (DAPT)) to prevent complications such as clot formation on the stent which may lead to a heart attack. Diabetic patients and those presenting with a heart attack at the time of stent placement are at increased risk for clot formation. However, little is known of the healing responses after stent placement in these populations. Currently all patients receiving DES are advised to complete DAPT for twelve months although more personalized durations of DAPT based on stent healing would reduce both clot formation and potential bleeding from the blood thinners, thereby improving the long-term safety of DES. Intracoronary optical frequency domain imaging (OFDI) is a novel high resolution invasive imaging technique that has the ability to evaluate stent healing at follow-up. Among the commercially available coated stents used in the U.S., the zotarolimus eluting stents (RESOLUTE Integrity, Medtronic, Minneapolis, MN) has demonstrated superior healing in both preclinical and clinical studies. The purpose of this trial is to determine the healing responses of the RESOLUTE Integrity stent as detected by OFDI in patients with and without diabetes presenting with ACS. Specifically, in this observational study, the study team will investigate non-insulin dependent diabetics and non-diabetics in the setting of ACS and RESOLUTE Integrity stent placement. The investigators hypothesize that healing responses in patients with non-insulin dependent diabetes will be similar to those without diabetes presenting with ACS and that a majority of patients will demonstrate complete healing as determined by OFDI measurements.

Conditions

Coronary Artery Disease

Keywords

Angioplasty; Atherosclerosis; Wound Healing

Outcome Measures

Primary Outcomes (1)

• Percent Stent Coverage

  Assessment of vascular healing 6 months after Resolute Integrity placement in non-diabetic patients and patients with non-insulin dependent diabetes presenting with acute coronary syndrome (ACS) using optical frequency domain imaging (OFDI). Vascular healing will be measured by percent covered stents as determined by OFDI. A higher percentage of stent coverage indicates increased endothelial regrowth, which is an essential component for the maintenance of long-term luminal patency.

  6 months

Study Arms (2)

Non-diabetic patients receiving the Resolute stent

EXPERIMENTAL

Non-diabetic patients presenting with Acute Coronary Syndrome (ACS), receiving the Resolute stent.

Device: Resolute Integrity stent

Diabetic patients receiving the Resolute stent

EXPERIMENTAL

Non-insulin dependent diabetes mellitus (NIDDM) patients presenting with Acute Coronary Syndrome (ACS), receiving the Resolute stent.

Device: Resolute Integrity stent

Interventions

Resolute Integrity stent DEVICE

Drug eluting stents used to treat coronary artery blockages

Diabetic patients receiving the Resolute stent; Non-diabetic patients receiving the Resolute stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient requiring percutaneous transluminal coronary interventions (PTCI) for acute coronary syndrome (ACS) and meeting criteria (as determined by the performing physician) for Resolute Integrity stent placement.

You may not qualify if:

• ST segment elevation MI (STEMI)
• stable angina
• current or planned pregnancy (for women of childbearing age)
• treatment of \> 2 lesions during the index hospitalization
• insulin dependent diabetic patients at the time of stent placement
• use of overlapping stents.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Related Publications (2)

• Kim JS, Jang IK, Fan C, Kim TH, Kim JS, Park SM, Choi EY, Lee SH, Ko YG, Choi D, Hong MK, Jang Y. Evaluation in 3 months duration of neointimal coverage after zotarolimus-eluting stent implantation by optical coherence tomography: the ENDEAVOR OCT trial. JACC Cardiovasc Interv. 2009 Dec;2(12):1240-7. doi: 10.1016/j.jcin.2009.10.006.

  PMID: 20129551 BACKGROUND

• Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.

  PMID: 17438147 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

Due to low enrollment there were not enough participants to provide 80% power for the comparison between the study arms, therefore, statistical analyses were not performed.

Results Point of Contact

• Title: Henry Liberman, MD
• Organization: Emory University

hliberm@emory.edu

404-686-2503

Study Officials

• Henry Liberman, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: February 20, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-04

Locations

US (1)