OPTIMIZE IDE for the Treatment of ACS
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-007488
NCT ID: NCT03190473
Sponsor Protocol Number: IP-15-001
About this study
Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.50 mm - 4.00 mm
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Subject is an eligible candidate for percutaneous coronary intervention (PCI)
- Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
- Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
- Subject has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria
- Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.50 mm and ≤ 4.00 mm
Exclusion Criteria:
- The subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
- The subject's target lesion(s) is located in the left main artery
- The subject's target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate
- The subject's target lesion(s) is located within a saphenous vein graft or arterial graft
- The subject's target lesion(s) will be accessed via a saphenous vein graft or arterial graft
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Malcolm Bell, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available