Efficacy and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease

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

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-28

Study Completion Date

2022-03-18

Brief Summary

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

This study is to evaluation the efficacy and safety of Zotarolimus-Eluting Stent in patients with long coronary artery disease of 25 mm or longer.

Related Clinical Trials

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

Study on Absorbable Zinc Alloy Drug Eluting Coronary Stent System

NCT05477940

Coronary Heart Disease Drug Eluting Stent

UNKNOWN NA

Safety and Efficacy Study of Kaname Coronary Stent System for the Treatment of Patients With Coronary Artery Disease

NCT01004575

Coronary Artery Disease Angioplasty, Transluminal, Percutaneous Coronary

COMPLETED NA

Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent

NCT00960908

Coronary Artery Disease

UNKNOWN

Evaluation of Outcomes of EES Implantation for Unprotected Left Main Coronary Artery Stenosis (PRE-COMBAT 2)

NCT01348022

Coronary Artery Disease

COMPLETED

Acute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use (CHINA RESOLUTE INTEGRITY STUDY)

NCT02452736

Ischemic Heart Disease Cardiovascular Diseases Arteriosclerosis +1 more

COMPLETED PHASE3

Detailed Description

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

Study objectives:

From this observational prospective study, the efficacy and safety of Zotarolimus-Eluting Stent in patients with coronary artery disease longer than 25mm is planned to be investigated.

Background:

Long coronary artery lesions are observed in 20% of all coronary interventions, and are associated with poor clinical outcomes. Zotarolimus-Eluting Stents are a new type of stent that combines the advantages of an Endeavour Resolute stent (drug eluting stent) and Integrity stent (bare metal stent). In other words, BioLinx polymer is used which is an advantage of Endeavour Resolute stent to secure clinical efficiency through stable drug release while ensuring flexibility and excellent deliverability, which is the advantage of Integrity stent. To date, there are only few studies to evaluate the efficacy and safety of Zotarolimus-Eluting Stent in the treatment of coronary artery disease. Therefore, the investigators planned to carry out a multicenter, prospective observational study to evaluated the efficacy and safety of Zotarolimus-Eluting Stent in patients with long coronary artery disease of 25 mm or longer.

Conditions

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

Coronary Artery Disease Myocardial Ischemia Coronary Disease

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zotarolimus-Eluting Stent

Percutaneous coronary intervention using zotarolimus-eluting stent

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Age ≥ 19 years old
* Evidence of myocardial ischemia and coronary artery diameter stenosis≥ 50% and lesion length ≥ 25mm
* At least 2.5 mm diameter coronary vessel by visual estimation
* Patients treated with Zotarolimus-eluting stent

Exclusion Criteria

* Previous coronary stent implantation
* Patients perticipated in other clinical trials of drugs or device
* Target vessel saphenous vein graft
* In-stent re-stenosis lesion
* Contraindicated to anti-platelet agents or hypersensitivity
* Past history of malignancy within 5 years
* History of anaphylaxis to contrast agent
* Pregnancy and lactation
* Life expectancy \< 1-year
* End stage renal disease on dialysis

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No