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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02932995

Enrollment

Registered

2016-10-14

Start date

2016-10-31

Completion date

2020-12-31

Last updated

2016-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Stent Occlusion

Keywords

Optical Coherence Tomography, Drug-Eluting 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary ContactSang-Wook Kim, MD, PhD

swivus@gmail.com+82-6299-1260

Outcome results