BOLT Lithotripsy RESTORE ATK Trial

Bolt Medical

Status

Completed

Conditions

Peripheral Vascular Diseases

Peripheral Arterial Disease

Treatments

Device: Intravascular Lithotripsy

Study type

Interventional

Funder types

Industry

Identifiers

NCT05662787

TP-001701

Details and patient eligibility

About

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

Full description

The RESTORE (ATK) above 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.

Enrollment

97 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age of subject is ≥18.
Rutherford Clinical Category 2, 3, or 4.
Target lesion that is located in a native de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery)
Calcification is at least moderate. (presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion or absolute length ≥20mm.

Exclusion criteria

Planned major amputation of the target leg (above the ankle)
The use of chronic total occlusion (CTO) re-entry devices
CTOs greater than 80 mm in length
Lesions within 10 mm of ostium of the SFA
Significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g., iliac or common femoral) not successfully treated with percutaneous angioplasty (PTA) or stent and without complications