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BOLT Lithotripsy RESTORE BTK Trial

NCT05535907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-25

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Bolt Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2024-04-04
Completion
2024-04-04
FDA Device
Yes

Countries

  • Austria
  • Croatia
  • Germany
  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05535907 on ClinicalTrials.gov