Outcome of Endovascular Therapies in Chronic Femoropopliteal Occlusive Disease With Severe Calcification

NCT ID: NCT04716361

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-10
• Study Completion Date: 2024-12-31

Brief Summary

This study is a prospective, multicenter, real world, observational study, which aims at evaluating the safety, efficacy and economic cost of endovascular treatments for endovascular therapies in chronic femoropopliteal occlusive disease with severe calcification. It is estimated that 400 subjects diagnosed with chronic femoropopliteal occlusive disease with severe calcification and receive endovascular treatments will be enrolled in eight centers nationwide from January 2021 to December 2022. All the subjects will be under follow-up for two years. There is no restriction on the endovascular techniques. The primary outcomes include the technical success rate of each endovascular techniques and the reintervention rate driven by lesions' clinical symptoms.

Detailed Description

Arteriosclerosis obliterans (ASO) is a common disease in middle-aged and elderly people, which affects up to 30% people who are over 70 years in the general population. Its symptoms include claudication, rest pain and ischemic tissue loss depending on its severity. Nowadays, endovascular treatments have become the first-line therapy. If ASO is combined with severe calcification, the treatment will be much more challenging. The efficacy of plain old balloon angioplasty is limited. New devices including drug-coated balloon, intravascular Lithotripsy, directional atherectomy, Supera stent and drug-eluting stent offer another chance and better prognosis. The data of these new devices, however, are mainly from low quality evidence. Therefore, we start this prospective, multicenter, real world, observational study, providing new data on the safety, efficacy and health economics evaluation of endovascular treatments for endovascular therapies in chronic femoropopliteal occlusive disease with severe calcification.

Conditions

Femoropopliteal Artery Occlusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Rutherford stages 2-6

2. The target vessel (femoral and/or popliteal artery) has at least ≥90% stenosis or occlusion with the moderate to severe calcification (defined as >5 cm continuous calcification)

3. For patients with both lower limbs to be treated, the side with severer calcification is selected. If the calcification is similar in the two sides, the first one to be treated is selected.

4. At least one outflow artery (which is patent in > 1/3 length) in the calf connects the popliteal artery.

5. Patients who failed the first treatment because the guide wire could not pass through the lesion can still be selected if the second endovascular treatment succeeds.

6. There is no restriction on the types of endovascular techniques and devices.

Exclusion Criteria

1. Life expectation less than one year

2. There is several infection and/or major tissue loss in the leg. Even if after revascularization, patient still need amputation.

3. The quality of patients' life cannot be assessed by vascular quality of life questionnaire due to difficulties in communication.

4. Chronic femoropopliteal occlusive disease without calcification.

5. Patients with acute arterial thrombosis.

6. Limbs that have been treated with the femoral and popliteal artery bypass surgery.

7. Pregnant women

8. Allergic to contrast medium

9. Participating in other drug or device studies currently.

10. Systematic infection and/or coagulation disorders 14 days before the enrollment.

11. Patients have severe systematic disease that cannot be controlled currently such as severe heart, lung disease, live function disorder, end stage cancer, etc

12. Stroke, myocardial infarction, bleeding in the past 6 month

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ziheng Wu, M.D.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

The First Affliated Hospital, Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ziheng Wu, M.D.

Role: CONTACT

wuziheng@zju.edu.cn

0571-87236648

Facility Contacts

Ziheng Wu, M.D.

Role: primary

wuziheng@zju.edu.cn

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Other Identifiers

IIT20200011B

Identifier Type: -

Identifier Source: org_study_id