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CompletedNCT05662787RESTORE ATKUpdated Feb 7, 2025

BOLT Lithotripsy RESTORE ATK Trial

An interventional study of Intravascular Lithotripsy in Peripheral Arterial Disease and Peripheral Vascular Diseases, sponsored by Bolt Medical. Completed at 11 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-07.

Sponsored by Bolt Medical · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jun 2024, 2 years 4 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in Feb 2025.
Phase
Not applicable
Study type
Interventional
Enrollment
97
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

The RESTORE (ATK) above the knee study is a prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy System.

Read the detailed description

The RESTORE (ATK) above 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.

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Conditions studied

  • Peripheral Arterial Disease
  • Peripheral Vascular Diseases

Keywords

  • PAD
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In context

Peripheral Arterial Disease

1,573 studies on the registry are indexed under Peripheral Arterial Disease; 284 are open to participants now.

This study's enrollment of 97 is above the median of 73 across 1,078 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Bolt Medical is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age of subject is ≥18.
  • Rutherford Clinical Category 2, 3, or 4.
  • Target lesion that is located in a native de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery)
  • 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

Exclusion Criteria:

  • Planned major amputation of the target leg (above the ankle)
  • The use of chronic total occlusion (CTO) re-entry devices
  • CTOs greater than 80 mm in length
  • Lesions within 10 mm of ostium of the SFA
  • Significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g., iliac or common femoral) not successfully treated with percutaneous angioplasty (PTA) or stent and without complications
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
97 participants (actual)

Study arms

  • Experimental
    Intravascular lithotripsy

    Device: Intravascular Lithotripsy

Interventions

  • DeviceIntravascular Lithotripsy

    Enhancing percutaneous transluminal angioplasty by utilizing delivery of IVL to disrupt calcium in above the knee lesions prior to full balloon dilatation at low pressures

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What researchers measure

Primary outcomes

  1. Primary Effectiveness Endpoint

    Post-treatment residual diameter stenosis of \< 50% of the target lesion (with or without adjunctive PTA therapy and/or stenting)

    Time frame: Immediately after the intervention/procedure/surgery

  2. Primary Safety Endpoint

    Composite of New-onset Major Adverse Events (MAEs)

    Time frame: Within 30 days following procedure

Secondary outcomes

  1. Freedom from Major Adverse Events (MAEs) within 6 months.

    Freedom from MAE within 6 months

    Time frame: Within 6 months following procedure

  2. Residual diameter stenosis of <50% of the target lesion (without adjunctive PTA or stent therapy)

    Residual diameter stenosis of \<50% of the target lesion (without adjunctive PTA or stent therapy)

    Time frame: Immediately after the intervention/procedure/surgery

  3. Residual diameter stenosis of <30% of the target lesion (without adjunctive PTA or stent therapy)

    Residual diameter stenosis of \<30% of the target lesion (without adjunctive PTA or stent

    Time frame: Immediately after the intervention/procedure/surgery

  4. Target lesion patency - freedom from > 50% restenosis (assessed by DUS)

    Target lesion patency - freedom from \> 50% restenosis (assessed by DUS)

    Time frame: 30 days following procedure

  5. Target lesion patency - freedom from > 50% restenosis (assessed by DUS)

    Target lesion patency - freedom from \> 50% restenosis (assessed by DUS)

    Time frame: 6 months following procedure

  6. Freedom from Target Lesion Revascularization (TLR) at 6 months

    Freedom from Target Lesion Revascularization (TLR) at 6 months

    Time frame: 6 months following procedure

  7. Ankle-Brachial Index (ABI) of the target limb at all planned follow-up time points

    Ankle-Brachial Index (ABI) of the target limb at all planned follow-up time points

    Time frame: at discharge after index procedure, 30 days following procedure, 6 months following procedure

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Study locations

11 sites
  • Medical University of Graz
    Graz, Austria
  • Universitätsklinik für Innere Medizin II
    Vienna, 1090, Austria
  • Mein Hanusch Krankenhaus
    Vienna, Austria
  • University Hospital of Split
    Split, Croatia
  • Klinikum Hochsauerland GmbH
    Arnsberg, Germany
  • Universitätsklinikum Freiburg Universitäts-Herzzentrum
    Bad Krozingen, Germany
  • MVZ CCB Frankfurt und Main-Taunus GbR
    Frankfurt, 60389, Germany
  • MVZ CCB Frankfurt und Main-Taunus GbR
    Frankfurt, Germany
  • Universitätsklinikum Münster (UKM)
    Münster, 48149, Germany
  • St. Franziskus-Hospital GmbH
    Münster, D-48145, Germany
  • GRN Klinik Weinheim
    Weinheim, Germany
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References and documents

Publications

  • Brodmann M, Schlager O, Werner M, Piorkowski M, Korosoglou G, Lichtenberg M, Schwindt A, Zeller T. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day and 6-Month Outcomes from the RESTORE ATK Study. J Vasc Interv Radiol. 2026 Jun;37(6):108695. doi: 10.1016/j.jvir.2026.108695. Epub 2026 Mar 9. PubMed 41812992 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05662787
Lead sponsor
Bolt Medical
Responsible party
Sponsor
First posted
Dec 23, 2022
Start date
Jan 19, 2023
Primary completion
Jun 20, 2024
Completion
Jul 30, 2024
Last update
Feb 7, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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