Clinical trial NCT04716361: Outcome of Endovascular Therapies in Chronic Femoropopliteal Occlusive Disease With Severe Calcification
Official title: Clinical and Economic Outcome of Endovascular Therapies in Chronic Femoropopliteal Occlusive Disease With Severe Calcification (The Evolution Study): a Prospective, Multi-center，Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femoropopliteal Artery Occlusion
Keywords: Peripheral artery disease
Calcification
Endovascular treatment
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic femoropopliteal occlusive disease with severe calcification

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.

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:

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

Primary outcomes:
measure: Technical success rate
timeFrame: 1 week
measure: The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional
timeFrame: 1 month
measure: The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional
timeFrame: 6 months
measure: The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional
timeFrame: 12 months
measure: The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional
timeFrame: 18 months
measure: The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional
timeFrame: 24 months
Secondary outcomes:
measure: Vascular quality of life questionnaire(VascuQol)
timeFrame: 1 month,6 months,12 months,18 months and 24 months
measure: Incidence of severe adverse events
timeFrame: 1 month,6 months,12 months,18 months and 24 months
measure: Patency of the target vessel
timeFrame: Patency of the target vessel. [ Time Frame: 1 month,6 months,12 months,18 months and 24 months
measure: Health economics evaluation
timeFrame: 24 months
measure: Wound, Ischemia, and foot infection(WIFI) classification system
timeFrame: 1 month,6 months,12 months,18 months and 24 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affliated Hospital, Zhejiang University, School of Medicine
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Ziheng Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
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