Peripheral Arterial Disease, Peripheral Vascular Diseases
Conditions
Keywords
PAD
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.
Interventions
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
Sponsors
Bolt Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy system
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint | 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 | Within 30 days following procedure | Composite of New-onset Major Adverse Events (MAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual diameter stenosis of <30% 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 |
| Target lesion patency - freedom from > 50% restenosis (assessed by DUS) | 30 days following procedure | Target lesion patency - freedom from \> 50% restenosis (assessed by DUS) |
| Freedom from Major Adverse Events (MAEs) within 6 months. | Within 6 months following procedure | Freedom from MAE within 6 months |
| 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 | Ankle-Brachial Index (ABI) of the target limb at all planned follow-up time points |
| Freedom from Target Lesion Revascularization (TLR) at 6 months | 6 months following procedure | Freedom from Target Lesion Revascularization (TLR) at 6 months |
| 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 \<50% of the target lesion (without adjunctive PTA or stent therapy) |
Countries
Austria, Croatia, Germany
Outcome results
None listed