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BOLT Lithotripsy RESTORE ATK Trial | Clinical Trials | Clareo Health

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COMPLETEDNANCT05662787

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.

Lead sponsor: Bolt Medical•11 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Bolt Medical

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 7, 2025Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment97

Start dateJan 2023

Last updatedFeb 7, 2025

Condition

Peripheral Arterial Disease Peripheral Vascular Diseases

Locations shown

Medical University of Graz

Graz

Universitätsklinik für Innere Medizin II

Vienna

Mein Hanusch Krankenhaus

Vienna

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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