ISAR-DAPT (A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial)

A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02609698

Enrollment

906

Registered

2015-11-20

Start date

2015-08-31

Completion date

2019-06-30

Last updated

2015-11-20

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

Conditions

Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease

Keywords

Stent, Polymer-free, Antiplatelet therapy, Clopidogrel, DES, DAPT

Brief summary

This clinical trial studies patients treated with the Coroflex ISAR Stent for coronary artery disease in order for the objective of verifying the non-inferiority of results that among patients who were administered DAPT for 3 months compared to patients who were administered DAPT for 6 months, in terms of the efficacy and safety of DAPT.

Interventions

DEVICECoroflex ISAR

This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.

DRUG3 months DAPT

DRUG6 months DAPT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. Patients aged 19 or older 2. Patients who have submitted a written consent to participate in the clinical trial 3. De novo lesion 4. Patients scheduled for elective intervention to treat ischemic cardiovascular disease

Exclusion criteria

1. Patients with any contraindications or hypersensitivity related to antiplatelet therapy 2. Patients with Acute Myocardial Infarction (ST elevation myocardial infarction, Non ST elevation myocardial infarction) 3. Patients who are anticipated to receive treatment or surgery that may require desisting the administration of antiplatelet therapy for 2 weeks or longer during the period of the clinical trial 4. Chronic total occlusion (CTO) lesions, in-stent restenosis (ISR) 5. Patients experiencing cardiogenic shock 6. Women who are breastfeeding, pregnant, or desiring pregnancy 7. Patients with findings of hemorrhage 8. Patients with a life expectancy of less than 1 year 9. Patients who have received a drug-eluting stent (DES) procedure within the past 6 months 10. Any other patients judged by the investigator to be unsuitable for the trial

Design outcomes

Primary

Measure	Time frame	Description
MACE	12 months from the time of the stenting	Major Adverse Cardiac Events (MACE) (cardiac death, recurrent myocardial infarction, target lesion revascularization) at 12 months from the time of the procedure

Secondary

Measure	Time frame
MACE	6 months from the time of the stenting
Any death, cardiac death, MI, TLR, TVR	6 months from the time of the stenting
Any death, cardiac death, MI, Stroke, TLR, TVR	12 months from the time of the stenting

Countries

South Korea

Contacts

Primary ContactMyeong-Ho Yoon, Ph.D, MD

yoonmh65@hanmail.net,+82-31-219-4329

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026