BIO REsponse Adapted Combination Therapy Pilot Study

This is an interventional diagnostic trial for Peripheral Arterial Disease focused on measuring flow-limiting dissection, residual stenosis Read More

Inclusion Criteria:

• Subject has provided written informed consent before any study specific test or procedure and is willing and able to comply with the required follow-up visits and procedures
• Subject has a chronic, symptomatic lower limb ischemia defined as Rutherford categories 2 to 4

Angiographic criteria:

• Single lesion or consecutive single lesions with a healthy segment(s) of ≤ 2cm in-between
• De novo, restenotic or (re)occluded lesion(s) post Percutaneous Transluminal Angioplasty in the native superficial femoral artery (SFA) and or the proximal popliteal artery (PPA)
• Lesion(s) must be located at least 1 cm distal to the profunda femoris artery and at least 3 cm above the knee joint (radiographic joint space)
• Degree of stenosis ≥70% by visual angiographic assessment
• Vessel diameter ≥ 4 and ≤ 7 mm
• Patent inflow artery, free from significant lesion (>50%) as confirmed by angiography. Treatment of the target lesion is acceptable after successful treatment of inflow iliac and/or common femoral artery lesion. The inflow lesion cannot be treated with a DCB or a Drug Eluting Stent
• Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of the three vessels patent (<50% stenosis) to the ankle or foot with no planned intervention

Exclusion Criteria:

• Previously stented target lesion
• Target lesion/ previously treated with drug-coated balloon <12 months prior to enrollment.
• Use of atherectomy, laser or other debulking devices in the target SFA/PPA vessel during the index procedure.
• Failure to cross the target lesion with the guide wire
• Presence of a complication following pre-dilation of target lesion, which in the opinion of the investigator would not allow the procedure to be performed in accordance with the REACT approach
• Presence of aneurysm in the target vessel.
• Prior on planned major amputation (above the ankle) in the target limb
• Acute ischemia and/or acute thrombosis of the target SFA/PPA vessel prior to enrollment.
• Perforation of the target vessel as evidenced by extravasation of contrast media prior to enrollment
• Known hypersensitivity or contraindication to contrast media that, in the opinion of the investigator, cannot be adequately pre-medicated
• Known hypersensitivity/allergy to Paclitaxel or other components of the investigational devices and comparator (e.g., nitinol, amorphous silicon carbide, polymer)
• Known hypersensitivity or contraindication to antiplatelet, anticoagulant, thrombolytic medications that would be administered during the study
• Subject with uncorrected bleeding disorders
• Subject with renal failure
• Life expectancy less than 12 months due to other comorbidities, that in the investigators opinion, could limit subject ability to comply with the study required follow-up visits/procedure and threaten the study scientific integrity
• Pregnant, breast feeding, or plan to become pregnant in the next 12 months.
• Current participation in another investigational drug or device clinical study that has not completed the primary endpoint at the time of enrollment or that upon investigator judgment could clinically interferes with the current study endpoints