DXR Stent for Vascular Healing and Thrombus Formation: OCT Study

• Conditions: Coronary Stent Occlusion; Coronary Artery Disease

• Registration Number: NCT02932995
• Lead Sponsor: Chung-Ang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-14
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-19
• Primary Completion: 2017-10
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stent strut coverage (Incidence of uncovered strut)	6 month	Coronary angiography with OCT follow up

Secondary Outcome Measures

Name	Time	Method
Stent malapposition	6 month	Coronary angiography with OCT follow up
Stent thrombosis	6 month	Coronary angiography with OCT follow up

Trial Locations

Locations (6)

Jeju National University Hospital; 🇰🇷 Jeju, Korea, Republic of

KyungHee University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Konyang University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Ulsan university hospital; 🇰🇷 Ulsan, Korea, Republic of