DXR Stent for Vascular Healing and Thrombus Formation: OCT Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Significance of Pre-interventional Optical Coherence Tomography in Bioresorbable Vascular Scaffold Implantation

NCT02894697

Myocardial Ischemia

TERMINATED NA

OCT-Guided Stent Optimization for Short-Duration Dual Antiplatelet Therapy in Stable Angina

NCT07198529

Stable Angina Coronary Artery Disease

RECRUITING NA

The Comparative Study of OCT，Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent

NCT02219594

Coronary Heart Disease

UNKNOWN NA

Optical Coherence Tomography to Improve Clinical Outcomes During Coronary Angioplasty

NCT02065102

Angina

COMPLETED

PREcise Percutaneous Coronary Intervention for Stent OptimizatION in Treatment of COMPLEX Lesion (PRECISION-COMPLEX)

NCT05493904

Coronary Artery Disease Angina Pectoris

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Coronary Stent Occlusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DXR stent group

Patients who undergo coronary intervention with DXR stent

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No