BOLT Lithotripsy RESTORE BTK Trial

BOLT Lithotripsy RESTORE BTK Trial for PAD (RESTORE BTK)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Peripheral Vascular Disease
• Intervention / Treatment: Device: Intravascular Lithotripsy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medical University of Graz
• Croatia
  • Split, Croatia
    • University Hospital of Split
• Germany
  • Arnsberg, Germany
    • Klinikum Hochsauerland GmbH
• Lithuania
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santaros Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravascular lithotripsy	Device: Intravascular Lithotripsy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after the intervention/procedure/surgery

Collaborators and Investigators

• Sponsor: Bolt Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Actual): April 4, 2024
• Study Completion (Actual): April 4, 2024

Study Registration Dates

• First Submitted: September 3, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: PAD
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: TP-001700

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes