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Prospective, single-center, randomized Clinical Trial Protocol: efficacy and safety of different oversize S.M.A.R.T. Flex stent system in the treatment of femoropopliteal lesions (TASC II c-class)

Prospective, single-center, randomized Clinical Trial Protocol: efficacy and safety of different oversize S.M.A.R.T. Flex stent system in the treatment of femoropopliteal lesions (TASC II c-class)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021691
Enrollment
Unknown
Registered
2019-03-05
Start date
2019-03-05
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriosclerosis Occlusive Disease

Interventions

Experimental group:Use 0% oversize
Control group:10%OVERSIZE

Sponsors

General Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Comply with surgical treatment of femoral popliteal arterial bypass potential patients TASC II class C occluded lesion; 2. Rutherford grades 2-5; 3. Male and non-pregnant female patients aged more than 18 years; 4. The target lesion inflow vessel has lesion, but the target lesion has been successfully treated before treatment; 5. ABI 0.7 or TBI 0.5; 6. Angiography: (1) at least one unobstructed distal outflow artery; (2) the lesion can be predilated; (3) the reference vessel diameter is between 4.0mm and 7.5mm (must be measured rather than estimated).

Exclusion criteria

Exclusion criteria: 1. Be not suitable for vascular interventional surgery treatment (PTCA) patients; 2. Pregnancy and lactation female patients; 3. An unmanageable disease of proximal arterial occlusion; 4. Lower limb aneurysm; 5. Rutherford class 5 above and with active infection; 6. Known coagulation disorder; 7. Patients with known allergy to heparin, aspirin, other anticoagulation and antiplatelet therapy, contrast agents; 8. Patients with a life expectancy of less than one year; 9. Patients have participated in clinical trials of other drugs or devices, and have not completed the main endpoint follow-up; 10. Strokes rounding out the top three months; 11. Happened for two weeks MI MI or angina pectoris; 12. Preoperative renal exhaustion or chronic renal disease serum creatinine 14 days Every 1.73 m2; Or people on dialysis; 13. Thread can't through the target lesion (success through the target lesion refers to the there is no current limiting sandwich or without perforation; The distal end of the guidewire can reach and pass through the target lesion; 14. People who are ill or don't want to participate in this trial.

Design outcomes

Secondary

MeasureTime frame
The first patency rate of target lesions at 12 months after surgery;

Countries

China

Contacts

Public ContactDai Xiang chen

General Hospital of Tianjin

13302165917@163.com+86 13302165917

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026