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Completed

NCT Number: NCT05662787

BOLT Lithotripsy RESTORE ATK Trial

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases 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 (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.

Who can participate

Healthy volunteers accepted: No

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

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

  • 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

Treatment and study plan

Intravascular Lithotripsy

Device

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

Primary outcomes

  1. Primary Effectiveness Endpoint

    Time frame: Immediately after the intervention/procedure/surgery

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

  2. Primary Safety Endpoint

    Time frame: Within 30 days following procedure

    Composite of New-onset Major Adverse Events (MAEs)

Secondary outcomes

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

    Time frame: Within 6 months following procedure

    Freedom from MAE within 6 months

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

    Time frame: Immediately after the intervention/procedure/surgery

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

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

    Time frame: Immediately after the intervention/procedure/surgery

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

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

    Time frame: 30 days following procedure

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

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

    Time frame: 6 months following procedure

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

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

    Time frame: 6 months following procedure

    Freedom from Target Lesion Revascularization (TLR) at 6 months

  7. 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

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

Sponsors and collaborators

Lead sponsor

Bolt Medical

Industry

Registry information

Official study title

BOLT Lithotripsy RESTORE ATK Trial for PAD (RESTORE ATK)

Acronym: RESTORE ATK

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 23, 2022
Registry last updated
Feb 7, 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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