NCT06885177

TECTONIC CAD IVL IDE Study

TECTONIC CAD Intravascular Lithotripsy (IVL) IDE Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 335 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single-arm, open-label, multi-center IDE study with up to 55 US sites

Detailed description

The TECTONIC CAD IVL IDE Study is a prospective, single-arm, open-label, multi-center study to evaluate the safety and effectiveness of the Abbott Coronary IVL System to treat severely calcified, stenotic de novo coronary arteries prior to stenting in 335 subjects at up to 55 sites in the US. The clinical outcomes from the study will be compared to pre-specified performance goals (PG) established using medical/scientific literature. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the Abbott Coronary IVL System in the United States.

Conditions

• Coronary Artery Calcification
• Coronary Artery Disease
• Stenotic Coronary Lesion

Interventions

Type	Name	Description
DEVICE	Experimental	Participants will receive treatment with Abbott's Coronary IVL System followed by stenting.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-05-01
• Completion: 2028-06-01
• First posted: 2025-03-20
• Last updated: 2026-04-09

Locations

41 sites across 1 country: United States

Regulatory

• FDA-regulated device study