BOLT Lithotripsy RESTORE BTK Trial

Bolt Medical20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Disease Peripheral Vascular Disease

Interventions

Intravascular LithotripsyDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Medical University of Graz

Graz, Austria

University Hospital of Split

Split, Croatia

Klinikum Hochsauerland GmbH

Arnsberg, Germany

Vilnius University Hospital Santaros clinics

Vilnius, Lithuania

Outcomes

Primary Outcomes

Acute reduction in percent (%) diameter stenosis of target lesion

Primary Effectiveness Endpoint

Time frame: Immediately after the intervention/procedure/surgery

Composite of new-onset Major Adverse Events (MAEs)

Primary Safety Endpoint

Time frame: Within 30 days following procedure

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)

as assessed by quantitative angiography via core lab evaluation.

Time frame: Immediately after the intervention/procedure/surgery

Data from ClinicalTrials.gov

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