NCT05535907

BOLT Lithotripsy RESTORE BTK Trial

BOLT Lithotripsy RESTORE BTK Trial for PAD (RESTORE BTK)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bolt Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The RESTORE (BTK) below the knee study is a prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy System.

Detailed description

The RESTORE (BTK) below the knee study is a prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy System that was designed to enhance percutaneous transluminal angioplasty by utilizing delivery of intravascular lithotripsy (IVL) to disrupt calcium prior to full balloon dilatation at low pressures.

Conditions

• Peripheral Arterial Disease
• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Intravascular Lithotripsy	Enhancing percutaneous transluminal angioplasty by utilizing delivery of IVL to disrupt calcium in below the knee lesions prior to full balloon dilatation at low pressures

Timeline

• Start date: 2022-09-05
• Primary completion: 2024-04-04
• Completion: 2024-04-04
• First posted: 2022-09-10
• Last updated: 2025-07-25

Locations

4 sites across 4 countries: Austria, Croatia, Germany, Lithuania

Regulatory

• FDA-regulated device study