BOLT Lithotripsy RESTORE BTK Trial

Bolt Medical

Status

Completed

Conditions

Peripheral Vascular Disease

Peripheral Arterial Disease

Treatments

Device: Intravascular Lithotripsy

Study type

Interventional

Funder types

Industry

Identifiers

NCT05535907

TP-001700

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Age of subject is ≥18.
Rutherford Clinical Category 2 - 5.
Single or multiple target lesion(s) is/are located in a de novo artery distal to the trifurcation vessels and extends to and ends above the ankle
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:

Target lesion is within only lower extremity vessel with < 50% stenosis.
Significant stenosis (>50% stenosis) or occlusion of inflow tract (e.g., iliac or common femoral) not successfully treated with PTA, stent or Lithotripsy and without complications
Planned major amputation of the target leg.
Previously implanted stent in the treatment lesion