DXR Stent for Vascular Healing and Thrombus Formation: OCT Study

NCT02932995 — Unknown, 60 participants, Chung-Ang University

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

Registry	NCT02932995
Status	Unknown
Study type	Observational
Enrollment	60 (Estimated)
Sponsor	Chung-Ang University (Other); collaborators: Konyang University Hospital, Kyunghee University Medical Center, Korea University Guro Hospital, Ulsan University Hospital, Jeju National University Hospital
Conditions	Coronary Artery Disease, Coronary Stent Occlusion
Dates	start 2016-10-01, primary completion 2017-10-01 (estimated), completion 2020-12-01 (estimated), first posted 2016-10-14, last updated 2016-10-19
Locations	6 sites in South Korea

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
DXR stent group			Patients who undergo coronary intervention with DXR stent

+Outcome measures

Primary outcomes

Stent strut coverage (Incidence of uncovered strut) [6 month]: Coronary angiography with OCT follow up

Secondary outcomes

Stent malapposition [6 month]: Coronary angiography with OCT follow up
Stent thrombosis [6 month]: Coronary angiography with OCT follow up

Other outcomes

major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization) [1 year]: Clinical outcome follow up
long term major cardiovascular event major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization) [3 year]: Clinical outcome follow up

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (6)

Facility	City	Country
Konyang University Hospital	Daejeon	South Korea
Jeju National University Hospital	Jeju City	South Korea
KyungHee University Medical Center	Seoul	South Korea
Chung-Ang University Hospital	Seoul	South Korea
Korea University Guro Hospital	Seoul	South Korea
Ulsan university hospital	Ulsan	South Korea

+Investigators

Sang-Wook Kim, MD, PhD, Principal investigator, Chung-Ang University Hospital