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

ISAR-DAPT: Evaluation of Efficacy and Safety of 3 months DAPT group vs. 6 months DAPT group in Patients who treated with Coroflex ISAR stent; a Prospective, Multicenter, Randomized, Open-label Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003736

Enrollment

523

Registered

2019-04-10

Start date

2015-03-31

Completion date

Unknown

Last updated

2023-01-10

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

Conditions

None listed

Interventions

Medical Device : 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 administ

Eligibility

Sex/Gender

All

Inclusion criteria

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 procedure by Coroflex ISAR Stent to treat ischemic cardiovascular disease

Exclusion criteria

Exclusion criteria: 1. Patients with any contraindications or hypersensitivity related to antiplatelet therapy 2. Patients with Acute Myocardial Infarction (ST segment elevation myocardial infarction, Non ST segment 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
Major Adverse Cardiac Events (MACE) (cardiac death, recurrent myocardial infarction, target lesion revascularization)	—

Secondary

Measure	Time frame
Major Adverse Cardiac Events (MACE) (cardiac death, recurrent myocardial infarction, target lesion revascularization);cardiac death, recurrent myocardial infarction, target lesion revascularization,target vessel revascularization;cardiac death, recurrent myocardial infarction, target lesion revascularization,target vessel revascularization	—

Countries

Korea, Republic of

Contacts

Public ContactMyeong-Ho Yoon

Ajou University Hospital

yoonmh65@hanmail.net+82-31-219-5110

Outcome results