BOLT Lithotripsy RESTORE BTK Trial

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.

• Intravascular Lithotripsy (Device): 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

Primary outcomes

• Acute reduction in percent (%) diameter stenosis of target lesion [Immediately after the intervention/procedure/surgery]: Primary Effectiveness Endpoint
• Composite of new-onset Major Adverse Events (MAEs) [Within 30 days following procedure]: Primary Safety Endpoint

Secondary outcomes

• Procedural success, defined as the ability of the Bolt IVL System to achieve a post-Lithotripsy residual diameter stenosis of ≤50% (with or without adjunctive PTA therapy or stenting) [Immediately after the intervention/procedure/surgery]: as assessed by quantitative angiography via core lab evaluation.

Sex: All, ages: 18 Years to any

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