STAR-PAK Study: Evaluating the Safety and Efficacy of PAK® (Paclitaxel Coated Balloon) in Treating Atherosclerotic Femoro-Popliteal Lesions

The primary objective of the study is to evaluate the performance and the safety of the PAK® DCB Catheter in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and/or popliteal arteries (SFA/PA) of patients with symptomatic peripheral artery disease (PAD).

The study enrolls patients who have been diagnosed with peripheral artery disease with stenosis of the superficial femoral or popliteal artery and are qualified for endovascular revascularization.

Lower extremity peripheral artery disease may be asymptomatic or may be accompanied by clinical symptoms due to restricted blood flow to the lower extremities.

The management of a patient diagnosed with peripheral arteriosclerosis is primarily aimed at reducing symptoms of limb ischemia and improving blood supply to the limb, as well as seeking to halt the progression of the disease.

Treatment of lower extremity atherosclerosis with percutaneous methods is a well-known minimally invasive and recommended treatment for lower extremity ischemia.

A maximum of 120 patients will be included in the study. All patients included in the study will receive treatment with the investigational device.

The study will use the PAK balloon catheter, which is CE certified and approved for the treatment of patients with peripheral vascular disease. That is, it is also used as standard outside the study. The test procedure with the study device is in accordance with its registration and instructions for use.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Written informed consent of the patient to participate in the study.
3. Symptoms of lower limb ischemia defined by Rutherford classification from 2 to 4.
4. At least one de novo or restenotic lesion, in SFA and/or PA defined as a lesion with a proximal origin \>10mm from SFA origin and a distal end above the knee joint (at least 3 cm above bottom of the femur- P1).
5. Target Lesion \>60% stenosis in the SFA or PA (based on angio-CT and/or confirmed in angiography).
6. Target Lesion \<150 mm that consists of no more than two adjacent lesions ≤ 25mm apart and is able to be completely covered with inflation of single investigated PAK DCB (with minimum of \>5mm proximal and distal margin.

   Note: Adjacent or tandem lesions must be treated as a single lesion.
7. Reference Vessel Diameter (RVD) between 4.0 and 8.0mm and within treatment range of PAK® DCB to be used 1:1 at the target lesion.
8. Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant ≥50% angiographic stenosis from origin to ankle.
9. In-flow vessel (both iliac and femoral) without significant ≥50% angiographic stenosis or successful treatment (≤30% residual stenosis with no complications) of a diseased in-flow vessel at least 30 days prior to the index procedure.

Note: treatment of contralateral iliac arteries is allowed.

Exclusion Criteria:

1. Life expectancy less than 2 years.
2. Suspected or detected malignancy without completed treatment (not considered cured).
3. Planned surgical or interventional procedures within 30 days after the study procedure.
4. Known impaired renal function with GFR ≤30 mL/min per 1.73 m2 and/or elevated serum creatinine \> 2.5mg/dL or on dialysis.
5. Active inflammatory process at the site of the planned puncture.
6. Acute lower limb ischemia.
7. Non-atherosclerotic lesion (e.g. vasculitis, dysplasia).
8. Necessary concurrent non-target lesion interventions involving a re-entry device, atherectomy, laser, or ablation procedures, the use of a drug eluting stent, or treatment with any other drug coated balloon.
9. Massive calcifications of the treated lesion (defined as angiographic evidence of dense calcification present on both sides of the vessel wall on two orthogonal views and that extends \>50 continuous mm in length; reflective 3 or 4 on the PACSS scale https://doi.org/10.1002%2Fccd.25387).
10. Angiographically confirmed presence of a thrombus in the target lesion.
11. The target lesion requiring primary stenting.
12. Presence of perforation, dissection (Type D or worse) or other injury in target vessel at time of enrollment.
13. Previous bypass graft or stent at target vessel (must be greater than 20mm from target lesion), or iliac stent that cannot permit crossing by the treatment balloon within the introducer sheath Note: In-stent restenosis is not allowed.
14. Gastrointestinal or any other major bleeding in the past three months.
15. Known bleeding disorder or uncontrolled hypercoagulable disorder.
16. Myocardial infarction or any stroke within 30 days prior to the procedure.
17. Known intolerance to required medications (especially antiplatelets and heparin), contrast media (that cannot be adequately pre-medicated), nitinol or paclitaxel.
18. Pregnant and childbearing age women not using effective contraception.
19. Participation in another investigational study (before completing primary endpoint analysis) or previous enrollment to this study.