TECTONIC CAD IVL IDE Study
NCT06885177 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 335
Last updated 2026-04-29
Summary
A prospective, single-arm, open-label, multi-center IDE study with up to 55 US sites
Conditions
- Coronary Artery Calcification
- Coronary Artery Disease
- Stenotic Coronary Lesion
Interventions
- DEVICE
-
Experimental
Participants will receive treatment with Abbott's Coronary IVL System followed by stenting.
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-01
- Primary Completion
- 2026-05-31
- Completion
- 2028-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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