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Completed

NCT Number: NCT05535907

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz, Graz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

    Time frame: Immediately after the intervention/procedure/surgery

    Primary Effectiveness Endpoint

  2. Composite of new-onset Major Adverse Events (MAEs)

    Time frame: Within 30 days following procedure

    Primary Safety Endpoint

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)

    Time frame: Immediately after the intervention/procedure/surgery

    as assessed by quantitative angiography via core lab evaluation.

Sponsors and collaborators

Lead sponsor

Bolt Medical

Industry

Registry information

Official study title

BOLT Lithotripsy RESTORE BTK Trial for PAD (RESTORE BTK)

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 10, 2022
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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