Noninferiority test of a sirolimus-ascorbic acid stent vs everolimus stent in heart disease patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In patients with chronic or acute coronary syndromes needing PCI, researchers compare the sirolimus-ascorbic acid eluting stent (D+Storm Novonix) to the widely used everolimus-eluting stent (Synergy XD) to see if it is not worse in preventing target lesion failure after one year. Target lesion failure combines cardiovascular death, target vessel heart attack, and need for revascularization at the treated site. The trial uses a noninferiority design to determine if the new stent provides comparable effectiveness and safety. Enrollment is open to adults 19 and older who can consent and meet the PCI criteria, with several safety exclusions in place.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult men and women aged 19 years or older
2. Patients with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who require percutaneous coronary intervention (PCI) (all-comers)
3. Patients who have voluntarily provided written informed consent to participate in the study

Exclusion Criteria:

1. Cardiogenic shock within 48 hours prior to the procedure
2. Known hypersensitivity to sirolimus, everolimus, ascorbic acid, or stent components (e.g., cobalt-chromium alloy)
3. Patients unable to maintain dual antiplatelet therapy (DAPT), including aspirin and a P2Y12 inhibitor, for 1 year
4. Women who are pregnant, breastfeeding, or of childbearing potential who meet any of the following:

   * Have not confirmed a negative pregnancy test prior to enrollment
   * Do not agree to use, or are unlikely to maintain, an acceptable method of contraception during the study period
5. Clinically significant abnormalities identified during study visits, physical examination, laboratory tests, or electrocardiogram (ECG) that, in the investigator's judgment, may interfere with the safe completion of the study
6. Life expectancy of less than 1 year or presence of serious non-cardiac conditions that may affect compliance with the study protocol
7. Patients who are unwilling or unable to comply with the study protocol

Where it's running

• Asan Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Jung-hee Ham Project Manager, Registered Nurse
• Email: cvcrc5@amc.seoul.kr
• Phone: 82-2-3010-4728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.