CompletedNo phase
BOLT Lithotripsy RESTORE ATK Trial
Key facts
- Who runs it
- Bolt Medical
- Where
- Austria, Croatia, and Germany10 sites in 3 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 97 people enrolled
- Started
- 19 Jan 2023
- Ended
- 30 Jul 2024
- Type of study
- Interventional
- Treatments tested
- Intravascular Lithotripsy
- Record updated
- 7 February 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
This trial has no sites in United States.
It has sites in 3 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 group in the trial
- Intravascular lithotripsyTreatment being tested
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- BOLT Lithotripsy RESTORE ATK Trial for PAD (RESTORE ATK)
- Publications
- Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day and 6-Month Outcomes from the RESTORE ATK Study.Journal of vascular and interventional radiology : JVIR, 2026
- Record updated
- 7 February 2025