Optical Frequency Domain Imaging (OFDI) and Vascular Healing After Stent Placement
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Resolute Integrity stent
Intervention type(s): Device
Intervention description(s): Drug eluting stents used to treat coronary artery blockages
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Angioplasty; Atherosclerosis; Wound Healing