Clinical trial NCT05662787: BOLT Lithotripsy RESTORE ATK Trial
Official title: BOLT Lithotripsy RESTORE ATK Trial for PAD (RESTORE ATK)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Peripheral Vascular Diseases
Keywords: PAD
Lead sponsor: Bolt Medical
Sponsor class: INDUSTRY
First posted: 2022-12-23
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy system
Primary purpose: TREATMENT

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.

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 criteria: 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

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: Immediately after the intervention/procedure/surgery
measure: Primary Safety Endpoint
timeFrame: Within 30 days following procedure
Secondary outcomes:
measure: Freedom from Major Adverse Events (MAEs) within 6 months.
timeFrame: Within 6 months following procedure
measure: Residual diameter stenosis of <50% of the target lesion (without adjunctive PTA or stent therapy)
timeFrame: Immediately after the intervention/procedure/surgery
measure: Residual diameter stenosis of <30% of the target lesion (without adjunctive PTA or stent therapy)
timeFrame: Immediately after the intervention/procedure/surgery
measure: Target lesion patency - freedom from > 50% restenosis (assessed by DUS)
timeFrame: 30 days following procedure
measure: Target lesion patency - freedom from > 50% restenosis (assessed by DUS)
timeFrame: 6 months following procedure
measure: Freedom from Target Lesion Revascularization (TLR) at 6 months
timeFrame: 6 months following procedure
measure: Ankle-Brachial Index (ABI) of the target limb at all planned follow-up time points
timeFrame: at discharge after index procedure, 30 days following procedure, 6 months following procedure
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
city: Vienna
country: Austria
facility: Universitätsklinik für Innere Medizin II
city: Vienna
country: Austria
facility: Mein Hanusch Krankenhaus
city: Split
country: Croatia
facility: University Hospital of Split
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland GmbH
city: Bad Krozingen
country: Germany
facility: Universitätsklinikum Freiburg Universitäts-Herzzentrum
city: Frankfurt
country: Germany
facility: MVZ CCB Frankfurt und Main-Taunus GbR
city: Frankfurt
country: Germany
facility: MVZ CCB Frankfurt und Main-Taunus GbR
city: Münster
country: Germany
facility: Universitätsklinikum Münster (UKM)
city: Münster
country: Germany
facility: St. Franziskus-Hospital GmbH
city: Weinheim
country: Germany
facility: GRN Klinik Weinheim
Study officials:
References: