BOLT Lithotripsy RESTORE ATK Trial

Bolt Medical97 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Disease Peripheral Vascular Diseases

Interventions

Intravascular LithotripsyDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary Effectiveness Endpoint

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

Time frame: Immediately after the intervention/procedure/surgery

Primary Safety Endpoint

Composite of New-onset Major Adverse Events (MAEs)

Time frame: Within 30 days following procedure

Secondary Outcomes

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

Freedom from MAE within 6 months

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 30 days following procedure

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

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

Data from ClinicalTrials.gov

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