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Single-center, Non-randomized, Single-arm study for assessing the safety and efficacy of TurboHawkTM in the treatment of chronic occlusive lesions of lower extremity femoral-popliteal artery

Single-center, Non-randomized, Single-arm study for assessing the safety and efficacy of TurboHawkTM in the treatment of chronic occlusive lesions of lower extremity femoral-popliteal artery

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023761
Enrollment
Unknown
Registered
2019-06-11
Start date
2019-06-11
Completion date
Unknown
Last updated
2019-06-17

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

Conditions

chronic occlusive lesions of lower extremity femoral-popliteal artery

Interventions

Case series:plaques rotary cutting

Sponsors

General Surgery Department of Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 80 years; 2. Lower extremity arterial occlusion (PAD) with Rutherford rating between 2 and 5; 3. Common femoral artery, superficial femoral artery, popliteal artery (= 70%) or occlusional lesions; 4. Lesion type: atherosclerotic plaque; Calcified plaque; Fibrotic plaque; 5. The total length of lesions is not limited; 6. Be able to make sense for the purpose of the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with plasma Cr level more than 150 mumol/L; 2. Acute and subacute thrombosis patients requiring thrombolysis and thrombolysis removal; 3. Patients with non-transluminal lesions; 4. Patients who are known to be allergic to aspirin, heparin, bolivar, contrast agent, etc.; 5. Patients who have participated in the clinical trial of drugs or other medical devices that may interfere with this clinical trial in the past 3 months; 6. Pregnant and lactating women; 7. Patients with thrombocytopenic purpura or coagulation dysfunction; 8. Patients with a life expectancy of less than 12 months; 9. Patients who are unable or unwilling to participate in this study.

Design outcomes

Primary

MeasureTime frame
primary patency rate of target leisions for 12 months;

Countries

China

Contacts

Public ContactXiangchen Dai

Tianjin Medical University

13302165917@163.com+86 13302165917

Outcome results

None listed

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