BOLT Lithotripsy RESTORE ATK Trial

NCT05662787 | Completed DMC FDA Device

• 1 other identifier: TP-001701
• Study Type: interventional
• Target: 97
• Locations: 3 countries
• Sites: 11

Brief 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.

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Keywords

PAD

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

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

  Within 6 months following procedure

• 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)

  Immediately after the intervention/procedure/surgery

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

  30 days following procedure

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

  6 months following procedure

Study Arms (1)

Intravascular lithotripsy

EXPERIMENTAL

Device: Intravascular Lithotripsy

Interventions

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

Intravascular lithotripsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bolt Medical: lead

Study Sites (11)

Medical University of Graz

Graz, Austria

Location

Universitätsklinik für Innere Medizin II

Vienna, 1090, Austria

Location

Mein Hanusch Krankenhaus

Vienna, Austria

Location

University Hospital of Split

Split, Croatia

Location

Klinikum Hochsauerland GmbH

Arnsberg, Germany

Location

Universitätsklinikum Freiburg Universitäts-Herzzentrum

Bad Krozingen, Germany

Location

MVZ CCB Frankfurt und Main-Taunus GbR

Frankfurt, 60389, Germany

Location

MVZ CCB Frankfurt und Main-Taunus GbR

Frankfurt, Germany

Location

Universitätsklinikum Münster (UKM)

Münster, 48149, Germany

Location

St. Franziskus-Hospital GmbH

Münster, D-48145, Germany

Location

GRN Klinik Weinheim

Weinheim, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy system

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 23, 2022
• Study Start: January 19, 2023
• Primary Completion: June 20, 2024
• Study Completion: July 30, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

AU (3); CR (1); DE (7)