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

NCT04716361 | Unknown

• 1 other identifier: IIT20200011B
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoropopliteal Artery Occlusion

Keywords

Peripheral artery disease; Calcification; Endovascular treatment

Outcome Measures

Primary Outcomes (6)

• Technical success rate

  Successfully revascularize the target vessel. The residual stenosis is \<30% and there is no acute thrombosis occurred in the target vessel within 1 week post-operation.

  1 week

• The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional

  Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.

  1 month

• The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional

  Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.

  6 months

• The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional

  Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.

  12 months

• The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional

  Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.

  18 months

• The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional

  Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.

  24 months

Secondary Outcomes (5)

• Vascular quality of life questionnaire(VascuQol)

  1 month,6 months,12 months,18 months and 24 months

• Incidence of severe adverse events

  1 month,6 months,12 months,18 months and 24 months

• Patency of the target vessel

  Patency of the target vessel. [ Time Frame: 1 month,6 months,12 months,18 months and 24 months

• Health economics evaluation

  24 months

• Wound, Ischemia, and foot infection(WIFI) classification system

  1 month,6 months,12 months,18 months and 24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic femoropopliteal occlusive disease with severe calcification

You may qualify if:

• Rutherford stages 2-6
• 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)
• 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.
• At least one outflow artery (which is patent in \> 1/3 length) in the calf connects the popliteal artery.
• 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.
• There is no restriction on the types of endovascular techniques and devices.

You may not qualify if:

• Life expectation less than one year
• There is several infection and/or major tissue loss in the leg. Even if after revascularization, patient still need amputation.
• The quality of patients' life cannot be assessed by vascular quality of life questionnaire due to difficulties in communication.
• Chronic femoropopliteal occlusive disease without calcification.
• Patients with acute arterial thrombosis.
• Limbs that have been treated with the femoral and popliteal artery bypass surgery.
• Pregnant women
• Allergic to contrast medium
• Participating in other drug or device studies currently.
• Systematic infection and/or coagulation disorders 14 days before the enrollment.
• Patients have severe systematic disease that cannot be controlled currently such as severe heart, lung disease, live function disorder, end stage cancer, etc
• Stroke, myocardial infarction, bleeding in the past 6 month

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affliated Hospital, Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

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MeSH Terms

Conditions

Peripheral Arterial Disease; Calcinosis

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ziheng Wu, M.D.

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziheng Wu, M.D.

CONTACT

0571-87236648; wuziheng@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 20, 2021
• Study Start: December 10, 2020
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2024
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

CN (1)