Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen

REMODEL I: Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen

The objective of this first-in-human study is to assess the safety and effectiveness of the Serranator Sonic Intravascular Lithotripsy (IVL) System™ for the treatment of peripheral artery disease.

*Inclusion Criteria for Cohort A: ATK arm of the study:

Clinical:

• Subject is ≥ 18 years of age
• Target limb is Rutherford Clinical Category 2, 3 or 4
• Resting ABI of ≤0.90, or TBI ≤0.70 of the target limb

Angiographic:

• Subject must have a de novo target lesion in a native superficial femoral artery (SFA) or popliteal artery

• Reference vessel diameter (RVD) between 4.0 and 8.0mm

• Target lesion must have a diameter stenosis of ≥70%

• Lesion calcification is at least moderate

• Total planned target lesion length must be ≤150mm

• Chronic total occlusion lesion length is ≤100mm

• Subject has at least one patent tibial vessel on the target limb with runoff to the foot

  • Exclusion Criteria for Cohort A: ATK arm of the study:

Clinical:

• Rutherford Clinical Categories 0, 1, 5 and 6
• Subject with known pregnancy or is nursing
• Subject has acute or chronic renal disease, defined as serum creatinine of >2.5 mg/dL or >220 µmol/L or on dialysis

Angiographic:

• Target lesions >150mm by visual estimation

• Chronic total occlusions > 100mm by visual estimation

• No or mild calcium present in the target lesion

  • Inclusion Criteria for Cohort B: BTK arm of the study:

Clinical:

• Age of subject is ≥18
• Rutherford Clinical Category 2 - 5 (with tissue loss limited to the digits and no evidence of infection)

Angiographic:

• Single or two target lesion(s) located in a de novo artery distal to the trifurcation vessels

• Target vessel reference diameter is between 2.5mm and 4.0 mm

• Target lesion with diameter stenosis ≥50%

• Target lesion is ≤150mm in length

• Subject has at least one patent tibial vessel (>50%) with run-off to the foot.

• Calcification is at least moderate

  • Exclusion Criteria for Cohort B: BTK arm of the study:

Clinical:

• Rutherford Clinical Category 0,1 or 6
• Gangrene of the lower extremity
• Patient is pregnant or nursing

Angiographic:

• Target lesion is within only lower extremity vessel with < 50% stenosis
• Target lesion length exceeds 150mm
• Patient has chronic total occlusion of target lesion