DXR Stent for Vascular Healing and Thrombus Formation: OCT Study

Evaluation of DUAL Drug-eluting Stent ( DXR Stent) for Vascular Healing and Thrombus Formation : an Optical Coherence Tomography Study

The purpose of this study is to evaluate the efficacy of a novel dual drug-eluting stent (DXR stent), which slowly releases both cilostazol and paclitaxel, for strut coverage, malapposition, and thrombus formation, assessed by an optical coherence tomography.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Coronary Stent Occlusion

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 35365
    • Konyang University Hospital
  • Jeju, Korea, Republic of
    • Jeju National University Hospital
  • Seoul, Korea, Republic of, 06973
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 02447
    • KyungHee University Medical Center
  • Ulsan, Korea, Republic of, 44033
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who undergo coronary artery intervention with DXR stent

Description

Inclusion Criteria:

1. Patient

   • Age >=19 years
   • Clinically indicated to invasive coronary angiography
   • Patient capable and willing of giving written informed consent

2. Angiographic

   • coronary artery disease confined to native coronary artery
   • >50% diameter stenosis by invasive coronary angiography
   • reference diameter 2.5-4.0mm, lesion length ≤30 mm

Exclusion Criteria:

1. Patient

   • Inability to provide written informed consent
   • Serious comorbidity which may affect the trial by decision of investigators
   • Prior CABG to target vessel
   • Congestive heart failure with NYHA Class III or IV or left ventricular ejection fraction less than 30%
   • Prior ST elevation myocardial infarction within 72 hours from the procedure
   • Hemodynamic or electrical instability including shock
   • Serious coronary artery spasm, unrelated to catheter
   • Pregnancy or possible pregnant status
   • Allergy to iodinated contrast agent
   • Serum creatinine >=1.7 mg/dL or creatinine clearance <= 30 ml/min
   • ST elevation myocardial infarction

2. Angiographic (OCT)

   • Left main disease
   • Severely calcified lesion
   • Severely tortuous, or TIMI flow grade 0 or 1 by angiography, or inappropriate for OCT procedure by investigators' decision

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
DXR stent group; Patients who undergo coronary intervention with DXR stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent strut coverage (Incidence of uncovered strut)	Coronary angiography with OCT follow up	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent malapposition	Coronary angiography with OCT follow up	6 month
Stent thrombosis	Coronary angiography with OCT follow up	6 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization)	Clinical outcome follow up	1 year
long term major cardiovascular event major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization)	Clinical outcome follow up	3 year

Collaborators and Investigators

• Sponsor: Chung-Ang University
• Collaborators: Ulsan University Hospital; Korea University Guro Hospital; Jeju National University Hospital; Kyunghee University Medical Center; Konyang University Hospital
• Investigators: Principal Investigator: Sang-Wook Kim, MD, PhD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 14, 2016

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; Drug-Eluting Stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: C2015201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO