Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter.

Prospective, Multi-Center, Open, Single Arm Study for the Treatment of Patients Presenting De Novo Lesions in the Superficial Femoral and/or Popliteal Arteries Using a Kanshas Drug Coated Balloon Catheter.

Assessing the safety and effectiveness of the Kanshas Paclitaxel-coated Balloon Catheter in the treatment of de novo lesions in the superficial femoral (SFA) and/or popliteal arteries.

The KANSHAS 1 (K-1) trial investigates the inhibition of restenosis using the Kanshas Paclitaxel-coated Balloon Catheter in the treatment of de novo lesions in the superficial femoral and/or popliteal arteries.

This clinical study is a prospective, multi-center, open, single-arm study. Up to 50 patients will be enrolled at 2 sites in Belgium and 4 sites in Germany. Follow-ups are scheduled before discharge, at 1 month (Clinic Visit or Phone FU), 6 months, 1-year, 2-years (Clinic Visits), 3-, 4- and 5- years (Clinic Visits or Phone FU).

Primary outcome measure:

• freedom from device-and procedure-related death through 30 days.
• freedom from target limb amputations and clinically driven target lesion revascularization through 6 months.

Inclusion Criteria:

General:

1. Clinically significant symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery;

2. Able and willing to provide informed consent prior to study procedures;

3. Able and willing to comply with follow-up requirements;

4. Rutherford Clinical Category of 2-4;

5. Resting ABI of <0.9 or abnormal exercise ABI;

6. ≥18 years old;

7. Life expectancy is >2 year;

   Angiographic Criteria:

8. Cumulative lesion length ≥4 and ≤15 cm within the target vessel; Cumulative lesion consists of either a single de novo lesion or multiple lesions within the 4-15 cm segment; multiple lesions require to meet all the following;

   • Separated by a gap of ≤ 3 cm;
   • Able to be treated as a single lesion;
   • Total combined lesion length including 3cm gap meets requirements;

9. Lesion location starts ≥2 cm distal to the common femoral bifurcation and terminates at ≥2 cm proximal to the origin of the tibio-peroneal trunk;

10. Clinically and hemodynamically significant de novo stenosis (>70% stenosis by visual estimate) or occlusion;

11. Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;

12. Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;

13. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of ipsilateral iliac lesions); NOTE: Successful ipsilateral iliac artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.

14. At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been revascularized;

Exclusion Criteria:

1. Pregnant or lactating females;
2. Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries;
3. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy;
4. Known intolerance to study medications, paclitaxel or contrast agents;
5. Patient participating in another investigational device or drug study that has not reached the primary endpoint;
6. History of hemorrhagic stroke within 2 months;
7. Previous or planned surgical or interventional procedure within 30 days of the study procedure;
8. Diagnosed liver failure, renal failure, chronic kidney disease, unstable angina pectoris, or myocardial infarction within 30 days of the procedure;
9. Presence of significant stenosis or occlusion of the inflow tract that cannot be successfully treated prior to study consideration. Successful is defined as <30% residual stenosis of ipsilateral iliac artery with no major complications;
10. Acute thrombus in target vessel;
11. At site of target lesion, use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, brachytherapy);
12. Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥50% stenosis) may not be treated during the same procedure;
13. Has in-stent restenosis in the target lesion;
14. Previous treatment with a drug coated PTA balloon catheter or drug eluting stent in the target vessel within 12 months of the index procedure;
15. Previous peripheral bypass affecting the target limb;
16. Has injuries in the target vessel, such as major flow-limiting dissection ( > NHLBI Grade C) and perforation, requiring stenting prior to enrollment;
17. Obvious subintimal recanalization or intentional subintimal recanalization in the occlusive lesions;
18. Presence of severe calcification in the target lesions that precludes endovascular treatment. Severe calcification is defined as circumferential calcification involving ≥ 50% of vessel diameter.