Study to evaluate reduced antiplatelet therapy after angiolite stent implantation in patients with coronary artery disease

Phase 1

Recruiting

• Conditions: Coronary Artery Disease; MedDRA version: 20.0Level: PTClassification code: 10011078Term: Coronary artery disease Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-507015-35-00
• Lead Sponsor: Ivascular S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-23
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2932

Inclusion Criteria

Age =18 - < 95 years, Presence of one or more coronary artery stenosis of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.00 mm (no limitation on the number of treated lesions, vessels, or lesion length), Able to provide informed consent and willing to participate in the trial

Exclusion Criteria

Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt, Female who is breastfeeding at time of randomization, Women of childbearing potential. Defined: a woman is considered potential (WOBCP) following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. a postmenopausal state is defined as no menses for 12 months without an alternative medical cause, Prior PCI (not related to the study) performed in the last 45 days, Currently participating in another randomized controlled trial and not yet at its primary endpoint, Life expectancy less than one year due to non-cardiovascular comorbidity, Known severe hepatic impairment Child-Pug stage C, Planned non-cardiac surgery during the first month after PCI, unless dual antiplatelet therapy is maintained throughout the peri-surgical period, Planned coronary artery bypass graft (CABG) or any other cardiac surgery (valvular for instance) following index PCI, Active major bleeding or major surgery within the last 30 days, Known stroke (any type) within the 30 days prior to the randomization, Known pregnancy at time of randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified