PAD
Conditions
Interventions
FREEWAY-PTA:PTA with FREEWAY balloon
JOKER-PTA:PTA with JOKER balloon
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject with ischemia symptoms in lower limb and need for treatment of femoral and popliteal artery (classified as Rutherford class 2-5); 2. male or non-pregnant women with age >=18 years; 3. Target lesion consists of a single or/and multiple primary occlusion or/and stenotic lesion (or reocclusion or restenotic lesion) in femoral and popliteal artery with Diameter stenosis >=70% and a total lesion length =3 mm and <=8 mm by DSA; 5. Angiographic evidence of adequate distal run-off to the foot (<50% diameter stenosis); 6. Successfully cross the target lesion with a guide wire; 7. Target lesion can be covered by 2 FREEWAY balloons; 8. In flow is open or recanalized successfully (< 50% diameter stenosis); 9. Target lesion is suitable for treatment with FREEWAY balloon evaluated by investigator; 10. Subject signed and dated Patient Informed Consent (PIC) form, and willing to comply with all requirements, including follow-up visits and evaluations.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or plan for pregnancy in a year; 2. Any surgical procedure or intervention performed within 30 days prior to the index procedure or any elective procedure or intervention within 30 days post index procedure; 3. Rutherford classification of the target lesion could not be accurately evaluated; 4. Complicated with an aneurysm in abdominal aorta, iliac artery or popliteal artery; 5. Known coagulation disorders that cannot tolerate anti-platelet therapies; 6. Inability to tolerate to contrast media or other medicine used in the index procedure; 7. In the investigator's opinion subject is not suitable to intervention because of renal or hepatic insufficiency 8. Acute or sub acute thrombus or embolization in target vessel; 9. No normal vessel proximal to the lesion can be measured by Doppler ultrasound to get Blood flow velocity ratio 10. Severe calcification; 11. Target lesion received treatment with alternative therapy such as laser, atherectomy, cryoplasty, cutting/scoring balloon; 12. Target lesion has been previously treated with bypass surgery; 13.In the investigator's opinion subject is not suitable to enroll in this study of unlikely to comply with the follow-up schedule; 14. Subject is enrolled in another investigational device at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| target lesion revascularization (TLR) rate at 6 months post index procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;Procedural succes rate;ABI increased>=0.1;Primary and secondary patency at 6 months post procedure;severe complication rate at 30 days, 6 and 12 months;change of Rutherford classification;target lesion revascularization (TLR) rate at 12 months post index procedure; | — |
Countries
China
Contacts
Public ContactYinghua Zou
Outcome results
None listed