BOLT Lithotripsy RESTORE ATK Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-19

Study Completion Date

2024-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Arterial Disease Peripheral Vascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravascular lithotripsy

Group Type EXPERIMENTAL

Intravascular Lithotripsy

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No