BOLT Lithotripsy RESTORE ATK Trial

Peripheral Arterial Disease Clinical Trial

— RESTORE ATK  

Official title:

BOLT Lithotripsy RESTORE ATK Trial for PAD (RESTORE ATK)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05662787
• Other study ID #: TP-001701
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 19, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: Bolt Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 95
• Est. completion date: December 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bolt Medical

Countries where clinical trial is conducted

Austria,  Croatia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Primary Safety Endpoint	Composite of New-onset Major Adverse Events (MAEs)	Within 30 days following procedure
Secondary	Freedom from Major Adverse Events (MAEs) within 6 months.	Freedom from MAE within 6 months	Within 6 months following procedure
Secondary	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
Secondary	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
Secondary	Target lesion patency - freedom from > 50% restenosis (assessed by DUS)	Target lesion patency - freedom from > 50% restenosis (assessed by DUS)	30 days following procedure
Secondary	Target lesion patency - freedom from > 50% restenosis (assessed by DUS)	Target lesion patency - freedom from > 50% restenosis (assessed by DUS)	6 months following procedure
Secondary	Freedom from Target Lesion Revascularization (TLR) at 6 months	Freedom from Target Lesion Revascularization (TLR) at 6 months	6 months following procedure
Secondary	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