Optical Frequency Domain Imaging (OFDI) and Vascular Healing After Stent Placement Diabetics Presenting With Acute Coronary Syndrome

Coronary Artery Disease Clinical Trial

— OFDI-DM  

Official title:

Optical Frequency Domain Imaging (OFDI) Determined Stent Strut Coverage and Plaque Morphology After RESOLUTE Stent Placement in Non-Insulin Dependent Diabetics Presenting With Acute Coronary Syndrome (ACS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794949
• Other study ID #: IRB00057208
• Status: Completed
• Phase: N/A
• First received: November 7, 2012
• Last updated: January 5, 2017
• Start date: September 2013
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The long-term efficacy of drug eluting stents (DES) used to treat symptomatic coronary artery disease is limited by incomplete healing of the stented segment necessitating the use of dual anti-platelet therapy (DAPT) with aspirin and a thienopyridine to prevent these late thrombotic complications. Diabetic patients and those presenting with acute coronary syndrome (ACS) at the time of DES placement are at increased risk for late in stent thrombosis, however, little is known of the healing responses 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 thrombosis and bleeding, thereby improving the long-term safety of DES. Intracoronary optical frequency domain imaging (OFDI) is a novel high resolution invasive imaging modality with the potential to discern plaque morphology at stent placement and stent strut healing at follow-up. Among the commercially available coated stents used in the U.S., the zotarolimus eluting stents (RESOLUTE, Medtronic, Minneapolis, MN) has demonstrated superior endothelialization and long term safety data in both preclinical and clinical studies.

The purpose of this trial is to determine the healing responses to the RESOLUTE stent as detected by OFDI in patients with and without diabetes presenting with ACS. Specifically, investigators will 1) determine while using OFDI whether any difference in healing occurs in non-insulin dependent diabetic patients presenting with ACS after RESOLUTE stent placement at 6 months; 2) determine how initial plaque morphology and angiographic measures such as late loss correlate with stent strut healing; and 3) examine whether selected biomarkers have an utility in predicting stent strut healing by OFDI.

Investigators will conduct a clinical study that images subjects at baseline and at 6 months after stent placement with intracoronary OFDI. OFDI data will be utilized to determine plaque morphology prior to intervention, ensure adequate strut apposition and stent sizing immediately post deployment and to measure stent strut coverage at 6 month follow-up. Two follow-up imaging passes will be conducted to evaluate test-retest variability of the coverage measurement. In addition to assessing the feasibility of using the OFDI coverage metric in vivo, this data may provide information on the magnitude of coverage that can be expected at 6 months following RESOLUTE stents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Resolute Integrity stent
Drug eluting stents used to treat coronary artery blockages

Locations

Country	Name	City	State
United States	Emory University Hospital Midtown	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent stent coverage	Assessment of the frequency of vascular healing 6 months after RESOLUTE Integrity placement in patients with non-insulin dependent diabetes presenting with ACS using optical frequency domain imaging (OFDI). Vascular healing will be measured by percent covered stents as determined by OFDI.	6 months	No