DXR Stent for Vascular Healing and Thrombus Formation: OCT Study

Chung-Ang University

Status: Unknown

Conditions: Coronary Artery Disease; Coronary Stent Occlusion

Study type: Observational

Funder types: Other

Identifiers

NCT02932995

C2015201

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

DXR stent group

Description:

Patients who undergo coronary intervention with DXR stent