Clinical trial NCT02932995: DXR Stent for Vascular Healing and Thrombus Formation: OCT Study
Official title: Evaluation of DUAL Drug-eluting Stent ( DXR Stent) for Vascular Healing and Thrombus Formation : an Optical Coherence Tomography Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Coronary Stent Occlusion
Keywords: Optical Coherence Tomography
Drug-Eluting Stent
Lead sponsor: Chung-Ang University
Sponsor class: OTHER
Collaborators: name: Konyang University Hospital
name: Kyunghee University Medical Center
name: Korea University Guro Hospital
name: Ulsan University Hospital
name: Jeju National University Hospital
First posted: 2016-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who undergo coronary artery intervention with DXR stent

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stent strut coverage (Incidence of uncovered strut)
timeFrame: 6 month
Secondary outcomes:
measure: Stent malapposition
timeFrame: 6 month
measure: Stent thrombosis
timeFrame: 6 month
Other outcomes:
measure: major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization)
timeFrame: 1 year
measure: long term major cardiovascular event major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization)
timeFrame: 3 year
Locations:
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan university hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Sang-Wook Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: