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

Femoropopliteal Artery Occlusion Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04716361
• Other study ID #: IIT20200011B
• Status: Recruiting
• Start date: December 10, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Ziheng Wu, M.D.
• Phone: 0571-87236648
• Email: wuziheng[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Femoropopliteal Artery Occlusion

Locations

Country	Name	City	State
China	The First Affliated Hospital, Zhejiang University, School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (18)

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Bisdas T, Beropoulis E, Argyriou A, Torsello G, Stavroulakis K. 1-Year All-Comers Analysis of the Eluvia Drug-Eluting Stent for Long Femoropopliteal Lesions After Suboptimal Angioplasty. JACC Cardiovasc Interv. 2018 May 28;11(10):957-966. doi: 10.1016/j.jcin.2018.03.046. — View Citation

Bohme T, Romano L, Macharzina RR, Noory E, Beschorner U, Jacques B, Burgelin K, Flugel PC, Zeller T, Rastan A. Outcomes of directional atherectomy for common femoral artery disease. EuroIntervention. 2021 Jun 25;17(3):260-266. doi: 10.4244/EIJ-D-19-00693. — View Citation

Brodmann M, Schwindt A, Argyriou A, Gammon R. Safety and Feasibility of Intravascular Lithotripsy for Treatment of Common Femoral Artery Stenoses. J Endovasc Ther. 2019 Jun;26(3):283-287. doi: 10.1177/1526602819844998. Epub 2019 Apr 22. — View Citation

Caradu C, Lakhlifi E, Colacchio EC, Midy D, Berard X, Poirier M, Ducasse E. Systematic review and updated meta-analysis of the use of drug-coated balloon angioplasty versus plain old balloon angioplasty for femoropopliteal arterial disease. J Vasc Surg. 2019 Sep;70(3):981-995.e10. doi: 10.1016/j.jvs.2019.01.080. Epub 2019 May 21. — View Citation

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Cioppa A, Stabile E, Salemme L, Popusoi G, Pucciarelli A, Iacovelli F, Arcari A, Coscioni E, Trimarco B, Esposito G, Tesorio T. Combined use of directional atherectomy and drug-coated balloon for the endovascular treatment of common femoral artery disease: immediate and one-year outcomes. EuroIntervention. 2017 Feb 20;12(14):1789-1794. doi: 10.4244/EIJ-D-15-00187. — View Citation

Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH, Aboyans V, Aksoy M, Alexandrescu VA, Armstrong D, Azuma N, Belch J, Bergoeing M, Bjorck M, Chakfe N, Cheng S, Dawson J, Debus ES, Dueck A, Duval S, Eckstein HH, Ferraresi R, Gambhir R, Gargiulo M, Geraghty P, Goode S, Gray B, Guo W, Gupta PC, Hinchliffe R, Jetty P, Komori K, Lavery L, Liang W, Lookstein R, Menard M, Misra S, Miyata T, Moneta G, Munoa Prado JA, Munoz A, Paolini JE, Patel M, Pomposelli F, Powell R, Robless P, Rogers L, Schanzer A, Schneider P, Taylor S, De Ceniga MV, Veller M, Vermassen F, Wang J, Wang S; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019 Jul;58(1S):S1-S109.e33. doi: 10.1016/j.ejvs.2019.05.006. Epub 2019 Jun 8. Erratum In: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):492-493. Eur J Vasc Endovasc Surg. 2020 Jul;60(1):158-159. — View Citation

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He HP, Weng JC, Zhao Y, Cai SH, Zhang XL, Yin HH. Impact of Plaque Calcification and Stent Oversizing on Clinical Outcomes of Atherosclerotic Femoropopliteal Arterial Occlusive Disease Following Stent Angioplasty. Eur J Vasc Endovasc Surg. 2019 Aug;58(2):215-222. doi: 10.1016/j.ejvs.2019.01.025. Epub 2019 Mar 9. — View Citation

Kokkinidis DG, Jawaid O, Cantu D, Martinsen BJ, Igyarto Z, Valle JA, Waldo SW, Armstrong EJ. Two-Year Outcomes of Orbital Atherectomy Combined With Drug-Coated Balloon Angioplasty for Treatment of Heavily Calcified Femoropopliteal Lesions. J Endovasc Ther. 2020 Jun;27(3):492-501. doi: 10.1177/1526602820915244. Epub 2020 May 4. — View Citation

Mohapatra A, Saadeddin Z, Bertges DJ, Madigan MC, Al-Khoury GE, Makaroun MS, Eslami MH. Nationwide trends in drug-coated balloon and drug-eluting stent utilization in the femoropopliteal arteries. J Vasc Surg. 2020 Feb;71(2):560-566. doi: 10.1016/j.jvs.2019.05.034. Epub 2019 Aug 10. — View Citation

Okuno S, Iida O, Shiraki T, Fujita M, Masuda M, Okamoto S, Ishihara T, Nanto K, Kanda T, Takahara M, Uematsu M. Impact of Calcification on Clinical Outcomes After Endovascular Therapy for Superficial Femoral Artery Disease: Assessment Using the Peripheral Artery Calcification Scoring System. J Endovasc Ther. 2016 Oct;23(5):731-7. doi: 10.1177/1526602816656612. Epub 2016 Jul 1. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Vascular quality of life questionnaire(VascuQol)	The VascuQol was designed as a questionnaire containing five domains: pain (4 items), symptoms (4 items), activities (8 items), social (2 items), and emotional (7 items) to evaluate Health related quality of life (HRQL). Every item has seven response options, with scores ranging from 1 to 7. A total score is the sum of all 25 item scores divided by 25.And both the total score as well as the domain scores range from 1 (worst HRQL) to 7 (best HRQL).The lower the value, the poorer the quality of life.	1 month,6 months,12 months,18 months and 24 months
Secondary	Incidence of severe adverse events	Severe adverse events include anyone of the following: Myocardial infarction, ischemic stroke, cardiovascular mortality, acute limb ischemia, and major amputation of a vascular etiology.	1 month,6 months,12 months,18 months and 24 months
Secondary	Patency of the target vessel	The patency is assessed by the vascular ultrasound.	Patency of the target vessel. [ Time Frame: 1 month,6 months,12 months,18 months and 24 months
Secondary	Health economics evaluation	All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed.	24 months
Secondary	Wound, Ischemia, and foot infection(WIFI) classification system	The Wound, Ischemia, and foot Infection (WIfI) classification system is a composite outcome measure encompassing demographic changes and expanding techniques of revascularization to perform meaningful analyses of outcomes in the treatment of the threatened limb, including wound, ischemia and foot infection. Each index was evaluated by very low, low, moderate and high, the very low represents no risk, the high reveals high risk of amputation.	1 month,6 months,12 months,18 months and 24 months