Peripheral Arterial Disease, Peripheral Vascular Disease
Conditions
Keywords
PAD
Brief summary
The RESTORE (BTK) below 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 (BTK) below 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 below 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
Key Inclusion Criteria: * Age of subject is ≥18. * Rutherford Clinical Category 2 - 5. * Single or multiple target lesion(s) is/are located in a de novo artery distal to the trifurcation vessels and extends to and ends above the ankle * 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
* Target lesion is within only lower extremity vessel with \< 50% stenosis. * Significant stenosis (\>50% stenosis) or occlusion of inflow tract (e.g., iliac or common femoral) not successfully treated with PTA, stent or Lithotripsy and without complications * Planned major amputation of the target leg. * Previously implanted stent in the treatment lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute reduction in percent (%) diameter stenosis of target lesion | Immediately after the intervention/procedure/surgery | Primary Effectiveness Endpoint |
| Composite of new-onset Major Adverse Events (MAEs) | Within 30 days following procedure | Primary Safety Endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success, defined as the ability of the Bolt IVL System to achieve a post-Lithotripsy residual diameter stenosis of ≤50% (with or without adjunctive PTA therapy or stenting) | Immediately after the intervention/procedure/surgery | as assessed by quantitative angiography via core lab evaluation. |
Countries
Austria, Croatia, Germany, Lithuania
Outcome results
None listed