BOLT Lithotripsy RESTORE BTK Trial

NCT05535907 | Completed DMC FDA Device

• 1 other identifier: TP-001700
• Study Type: interventional
• Target: 20
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Peripheral Arterial Disease; Peripheral Vascular Disease

Keywords

PAD

Outcome Measures

Primary Outcomes (2)

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

  Primary Effectiveness Endpoint

  Immediately after the intervention/procedure/surgery

• Composite of new-onset Major Adverse Events (MAEs)

  Primary Safety Endpoint

  Within 30 days following procedure

Secondary Outcomes (1)

• 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

Study Arms (1)

Intravascular lithotripsy

EXPERIMENTAL

Device: Intravascular Lithotripsy

Interventions

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

Intravascular lithotripsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bolt Medical: lead

Study Sites (4)

Medical University of Graz

Graz, Austria

Location

University Hospital of Split

Split, Croatia

Location

Klinikum Hochsauerland GmbH

Arnsberg, Germany

Location

Vilnius University Hospital Santaros clinics

Vilnius, 08661, Lithuania

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy system

Study Record Dates

• First Submitted: September 3, 2022
• First Posted: September 10, 2022
• Study Start: September 5, 2022
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

CR (1); AU (1); DE (1); LI (1)