Peripheral Arterial DiseaseRESTORE ATKNCT05662787
BOLT Lithotripsy RESTORE ATK Trial
A study testing Intravascular Lithotripsy in people with Peripheral Arterial Disease and Peripheral Vascular Diseases, run by Bolt Medical at 11 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Vascular Diseases
- What is being tested?
- Intravascular Lithotripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 19 Jan 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Germany7 sites
Klinikum Hochsauerland GmbH
Arnsberg
Universitätsklinikum Freiburg Universitäts-Herzzentrum
Bad Krozingen
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt, 60389
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt
Universitätsklinikum Münster (UKM)
Münster, 48149
St. Franziskus-Hospital GmbH
Münster, D-48145
GRN Klinik Weinheim
Weinheim
Austria3 sites
Medical University of Graz
Graz
Universitätsklinik für Innere Medizin II
Vienna, 1090
Mein Hanusch Krankenhaus
Vienna
About this study
Official title: BOLT Lithotripsy RESTORE ATK Trial for PAD (RESTORE ATK)
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.
Read the 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.
- Being tested
- Intravascular Lithotripsy
- Keywords
- PAD
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Intravascular lithotripsy | Experimental | Not described Receives: Device: Intravascular Lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Post-treatment residual diameter stenosis of < 50% of the target lesion (with or without adjunctive PTA therapy and/or stenting)
Measured: Immediately after the intervention/procedure/surgery
Primary Safety Endpoint
Composite of New-onset Major Adverse Events (MAEs)
Measured: Within 30 days following procedure
Secondary outcomes (7)
Freedom from Major Adverse Events (MAEs) within 6 months.
Freedom from MAE within 6 months
Measured: 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)
Measured: 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
Measured: 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)
Measured: 30 days following procedure
Target lesion patency - freedom from > 50% restenosis (assessed by DUS)
Target lesion patency - freedom from > 50% restenosis (assessed by DUS)
Measured: 6 months following procedure
Freedom from Target Lesion Revascularization (TLR) at 6 months
Freedom from Target Lesion Revascularization (TLR) at 6 months
Measured: 6 months following procedure
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
Measured: at discharge after index procedure, 30 days following procedure, 6 months following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start19 Jan 2023
- Primary completion20 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy system
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bolt Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662787
- Sponsor's protocol ID
- TP-001701
- Acronym
- RESTORE ATK
- Status last verified
- Feb 2025
- First submitted
- 30 Nov 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Brodmann M, Schlager O, Werner M, Piorkowski M, Korosoglou G, Lichtenberg M, Schwindt A, Zeller T. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day and 6-Month Outcomes from the RESTORE ATK Study. J Vasc Interv Radiol. 2026 Jun;37(6):108695. doi: 10.1016/j.jvir.2026.108695. Epub 2026 Mar 9.
PubMed 41812992
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOLT Lithotripsy RESTORE ATK Trial for PAD (RESTORE ATK)
- ClinicalTrials.gov ID
- NCT05662787
- Acronym / sponsor ID
- RESTORE ATK / TP-001701
- Keywords
- PAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Bolt MedicalIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy system
| Arm | Type | Receives |
|---|---|---|
| Intravascular lithotripsy | Experimental | Device: Intravascular Lithotripsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular LithotripsyEnhancing percutaneous transluminal angioplasty by utilizing delivery of IVL to disrupt calcium in above the knee lesions prior to full balloon dilatation at low pressures | Device | Intravascular lithotripsy |
Primary outcome
Primary Effectiveness Endpoint
Time frame: Immediately after the intervention/procedure/surgery
Post-treatment residual diameter stenosis of < 50% of the target lesion (with or without adjunctive PTA therapy and/or stenting)
Primary Safety Endpoint
Time frame: Within 30 days following procedure
Composite of New-onset Major Adverse Events (MAEs)
7 secondary outcomes
Freedom from Major Adverse Events (MAEs) 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)
Time frame: Immediately after the intervention/procedure/surgery
Residual diameter stenosis of <30% of the target lesion (without adjunctive PTA or stent therapy)
Time frame: Immediately after the intervention/procedure/surgery
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)
Time frame: 6 months following procedure
Freedom from Target Lesion Revascularization (TLR) at 6 months
Time frame: 6 months following procedure
Ankle-Brachial Index (ABI) of the target limb at all planned follow-up time points
Time frame: at discharge after index procedure, 30 days following procedure, 6 months following procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Derived from this study: PubMed 41812992Brodmann M, Schlager O, Werner M, Piorkowski M, Korosoglou G, Lichtenberg M, Schwindt A, Zeller T. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day and 6-Month Outcomes from the RESTORE ATK Study. J Vasc Interv Radiol. 2026 Jun;37(6):108695. doi: 10.1016/j.jvir.2026.108695. Epub 2026 Mar 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular Lithotripsy in people with Peripheral Arterial Disease and Peripheral Vascular Diseases, run by Bolt Medical at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Austria, Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: Immediately after the intervention/procedure/surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05662787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025; AzTrials last refreshed its copy on 2 Nov 2026.