ClinicalTrialsFinder
RecruitingNCT06485622

Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans

Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans: a Prospective, Single-center, Observational Study

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Enrollment

400 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Arteriosclerosis Obliterans

Summary

This study is a prospective, single-center, observational study. In this study, we aim to evaluate the clinical outcome and cost-effectiveness of different treatments of lower extremity arterial occlusive disease. It is expected to include about 400 patients diagnosed with lower extremity arterial occlusive disease in our center from July 2024 to July 2026. All enrolled patients will be followed for three years. All patients diagnosed with arteriosclerosis obliterans (ASO) and all treatment techniques were included in this study. The primary outcomes include the Efficacy and Safety End Points of each techniques.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Age 18 years or older, gender is not limited.
  • Patients diagnosed with arteriosclerosis obliterans.
  • Rutherford stages 2-6.
  • When there are multiple stenosis lesions, the treatment of the most severe lesion is included.
  • Patients with at least one arterial occlusion ( iliac, femoral, popliteal, anterior tibial, posterior tibial, and/or peroneal artery) of the lower extremity were included.

Exclusion Criteria11

  • Malignant tumor
  • Alzheimer's disease
  • Blood disease or bleeding tendency
  • Heart Failure Grade III ~ IV
  • Pregnancy or lactation
  • An above-knee-below-knee amputation has been performed
  • Unable to accept therapeutic function tests
  • Life expectancy is less than six months
  • Combined with other diseases affecting walking
  • Cardiovascular and cerebrovascular events occurred within 3 months, including non-fatal myocardial infarction, unstable angina, stable angina, non-fatal ischemic stroke and hemorrhagic stroke
  • Patients with significant abnormal liver and renal function that the investigators judged to be clinically significant

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREopen bypass group

After heparinization, the target artery is clamped above and below the anastomosis. The target artery is dissected along the anterior wall, calcium portions or mural thrombus are removed. Graft (autologous or prosthetic graft) is cut obliquely and anastomosis suturing starts with distal angle. Next stage is tunnel creating for graft conduction.

PROCEDUREbare metal stent group

Bare metal stent implantation during the index procedure.

PROCEDUREplain old balloon angioplasty group

Only plain old balloon was used during the index procedure.

PROCEDUREdrug-coated balloon group

Drug-coated balloon was used during the index procedure.

PROCEDUREdirectional atherectomy group

Directional atherectomy (with or without drug-coated balloon) during the index procedure.

PROCEDUREhybrid repair group

Femoral artery arteriotomy. Further execute a direct endarterectomy femoral artery and from the mouth of a hip artery. Arteriotomy of the femoral artery is closed with a vascular patch use (synthetic or biological). Endovascular revascularization followed.

Locations(1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06485622