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BOLT Lithotripsy RESTORE ATK Trial | Clinical Trials | Clareo Health

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BOLT Lithotripsy RESTORE ATK Trial

BOLT Lithotripsy RESTORE ATK Trial for PAD (RESTORE ATK)

NCT05662787•Bolt Medical

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (11)

Medical University of Graz

Graz, Austria

Universitätsklinik für Innere Medizin II

Vienna, 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, Germany

MVZ CCB Frankfurt und Main-Taunus GbR

Frankfurt, Germany

Universitätsklinikum Münster (UKM)

Münster, Germany

St. Franziskus-Hospital GmbH

Münster, Germany

Key Dates

Start Date

January 19, 2023

Primary Completion Date

June 20, 2024

Completion Date

July 30, 2024

Last Updated

February 7, 2025

Enrollment

ACTUAL participants

Conditions

Peripheral Arterial DiseasePeripheral Vascular Diseases

Interventions

Intravascular Lithotripsy

DEVICE

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

NCT07472049

Peripheral Arterial DiseaseChronic Limb Threatening Ischemia

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RECRUITING

Advanta VXT and Flixene PMCF Registry

NCT07161583

Peripheral Arterial Disease

View study

RECRUITING

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: March 29, 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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BOLT Lithotripsy RESTORE ATK Trial

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Advanta VXT and Flixene PMCF Registry

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

VITUS Post-Market Registry

A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)