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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravascular lithotripsy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular Lithotripsy | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Safety Endpoint | Composite of New-onset Major Adverse Events (MAEs) | Within 30 days following procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Major Adverse Events (MAEs) within 6 months. | Freedom from MAE within 6 months | Within 6 months following procedure |
| Residual diameter stenosis of <50% of the target lesion (without adjunctive PTA or stent therapy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Austria | ||||
| Universitätsklinik für Innere Medizin II |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 15, 2025 | Oct 1, 2025 | 6 |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy system
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Residual diameter stenosis of <50% of the target lesion (without adjunctive PTA or stent therapy)
| 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 | 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) | 30 days following procedure |
| Target lesion patency - freedom from > 50% restenosis (assessed by DUS) | Target lesion patency - freedom from > 50% restenosis (assessed by DUS) | 6 months following procedure |
| Freedom from Target Lesion Revascularization (TLR) at 6 months | Freedom from Target Lesion Revascularization (TLR) at 6 months | 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 | at discharge after index procedure, 30 days following procedure, 6 months following procedure |
| Vienna |
| 1090 |
| Austria |
| Mein Hanusch Krankenhaus | Vienna | Austria |
| University Hospital of Split | Split | Croatia |
| Klinikum Hochsauerland GmbH | Arnsberg | Germany |
| Universitätsklinikum Freiburg Universitäts-Herzzentrum | Bad Krozingen | Germany |
| MVZ CCB Frankfurt und Main-Taunus GbR | Frankfurt | 60389 | Germany |
| MVZ CCB Frankfurt und Main-Taunus GbR | Frankfurt | Germany |
| Universitätsklinikum Münster (UKM) | Münster | 48149 | Germany |
| St. Franziskus-Hospital GmbH | Münster | D-48145 | Germany |
| GRN Klinik Weinheim | Weinheim | Germany |
| D002318 |
| Cardiovascular Diseases |