BOLT Lithotripsy RESTORE ATK Trial (RESTORE ATK)

BOLT Lithotripsy RESTORE ATK Trial for PAD (RESTORE ATK)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Peripheral Vascular Diseases
• Intervention / Treatment: Device: Intravascular Lithotripsy

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.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravascular lithotripsy	Device: Intravascular 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint	Post-treatment residual diameter stenosis of < 50% of the target lesion (with or without adjunctive PTA therapy and/or stenting)	Immediately after the intervention/procedure/surgery
Primary Safety Endpoint	Composite of New-onset Major Adverse Events (MAEs)	Within 30 days following procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from Major Adverse Events (MAEs) within 6 months.	Freedom from MAE within 6 months	Within 6 months following procedure
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)	Immediately after the intervention/procedure/surgery
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	Immediately after the intervention/procedure/surgery
Target lesion patency - freedom from > 50% restenosis (assessed by DUS)	Target lesion patency - freedom from > 50% restenosis (assessed by DUS)	30 days following procedure
Target lesion patency - freedom from > 50% restenosis (assessed by DUS)	Target lesion patency - freedom from > 50% restenosis (assessed by DUS)	6 months following procedure
Freedom from Target Lesion Revascularization (TLR) at 6 months	Freedom from Target Lesion Revascularization (TLR) at 6 months	6 months following procedure
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	at discharge after index procedure, 30 days following procedure, 6 months following procedure

Collaborators and Investigators

• Sponsor: Bolt Medical

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: PAD
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: TP-001701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes