Femoropopliteal Artery OcclusionNCT04716361
Outcome of Endovascular Therapies in Chronic Femoropopliteal Occlusive Disease With Severe Calcification
An observational study of Femoropopliteal Artery Occlusion, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoropopliteal Artery Occlusion
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic femoropopliteal occlusive disease with severe calcification
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310000
Ziheng Wu, M.D., wuziheng@zju.edu.cn
About this study
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
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.
Read the 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
- Keywords
- Peripheral artery disease, Calcification, Endovascular treatment
- Medical subject headings
- Peripheral Arterial Disease, Calcinosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Secondary outcomes (5)
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.
Measured: 1 month,6 months,12 months,18 months and 24 months
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.
Measured: 1 month,6 months,12 months,18 months and 24 months
Patency of the target vessel
The patency is assessed by the vascular ultrasound.
Measured: Patency of the target vessel. [ Time Frame: 1 month,6 months,12 months,18 months and 24 months
Health economics evaluation
All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed.
Measured: 24 months
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.
Measured: 1 month,6 months,12 months,18 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start10 Dec 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Femoropopliteal Artery OcclusionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ziheng Wu, M.D., Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716361
- Sponsor's protocol ID
- IIT20200011B
- Status last verified
- Feb 2023
- First submitted
- 10 Jan 2021
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dua A, Lee CJ. Epidemiology of Peripheral Arterial Disease and Critical Limb Ischemia. Tech Vasc Interv Radiol. 2016 Jun;19(2):91-5. doi: 10.1053/j.tvir.2016.04.001. Epub 2016 Apr 22.
PubMed 27423989Olinic DM, Spinu M, Olinic M, Homorodean C, Tataru DA, Liew A, Schernthaner GH, Stanek A, Fowkes G, Catalano M. Epidemiology of peripheral artery disease in Europe: VAS Educational Paper. Int Angiol. 2018 Aug;37(4):327-334. doi: 10.23736/S0392-9590.18.03996-2.
PubMed 29936722Conte 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.
PubMed 31182334Rocha-Singh KJ, Zeller T, Jaff MR. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. 2014 May 1;83(6):E212-20. doi: 10.1002/ccd.25387. Epub 2014 Feb 10.
PubMed 24402839Okuno 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.
PubMed 27369975He 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.
PubMed 30862415Tepe G, Beschorner U, Ruether C, Fischer I, Pfaffinger P, Noory E, Zeller T. Drug-Eluting Balloon Therapy for Femoropopliteal Occlusive Disease: Predictors of Outcome With a Special Emphasis on Calcium. J Endovasc Ther. 2015 Oct;22(5):727-33. doi: 10.1177/1526602815600156. Epub 2015 Aug 6.
PubMed 26250747Cassese S, Wolf F, Ingwersen M, Kinstner CM, Fusaro M, Ndrepepa G, Ibrahim T, Ott I, Lammer J, Krankenberg H, Fusaro M. Drug-Coated Balloon Angioplasty for Femoropopliteal In-Stent Restenosis. Circ Cardiovasc Interv. 2018 Dec;11(12):e007055. doi: 10.1161/CIRCINTERVENTIONS.118.007055.
PubMed 30562083Chen Z, Guo W, Jiang W, Wang F, Fu W, Zou Y, Deckers S, Li P, Popma JJ, Jaff MR. IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population. J Endovasc Ther. 2019 Aug;26(4):471-478. doi: 10.1177/1526602819852084. Epub 2019 Jun 17.
PubMed 31204595Caradu 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.
PubMed 31126769Brodmann 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.
PubMed 31006305Adams G, Shammas N, Mangalmurti S, Bernardo NL, Miller WE, Soukas PA, Parikh SA, Armstrong EJ, Tepe G, Lansky A, Gray WA. Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study. J Endovasc Ther. 2020 Jun;27(3):473-480. doi: 10.1177/1526602820914598. Epub 2020 Apr 3.
PubMed 32242768Bohme 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.
PubMed 32176618Bisdas 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.
PubMed 29798772Cioppa 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.
PubMed 28216476
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04716361
- Acronym / sponsor ID
- IIT20200011B
- Conditions
- Femoropopliteal Artery Occlusion
- Keywords
- Peripheral artery disease, Calcification, Endovascular treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic femoropopliteal occlusive disease with severe calcification
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical success rate
Time frame: 1 week
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.
The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional
Time frame: 1 month
Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.
The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional
Time frame: 6 months
Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.
The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional
Time frame: 12 months
Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.
The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional
Time frame: 18 months
Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.
The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional
Time frame: 24 months
Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.
5 secondary outcomes
Vascular quality of life questionnaire(VascuQol)
Time frame: 1 month,6 months,12 months,18 months and 24 months
Incidence of severe adverse events
Time frame: 1 month,6 months,12 months,18 months and 24 months
Patency of the target vessel
Time frame: Patency of the target vessel. [ Time Frame: 1 month,6 months,12 months,18 months and 24 months
Health economics evaluation
Time frame: 24 months
Wound, Ischemia, and foot infection(WIFI) classification system
Time frame: 1 month,6 months,12 months,18 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Background: PubMed 27423989Dua A, Lee CJ. Epidemiology of Peripheral Arterial Disease and Critical Limb Ischemia. Tech Vasc Interv Radiol. 2016 Jun;19(2):91-5. doi: 10.1053/j.tvir.2016.04.001. Epub 2016 Apr 22.
- Background: PubMed 29936722Olinic DM, Spinu M, Olinic M, Homorodean C, Tataru DA, Liew A, Schernthaner GH, Stanek A, Fowkes G, Catalano M. Epidemiology of peripheral artery disease in Europe: VAS Educational Paper. Int Angiol. 2018 Aug;37(4):327-334. doi: 10.23736/S0392-9590.18.03996-2.
- Background: PubMed 31182334Conte 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.
- Background: PubMed 24402839Rocha-Singh KJ, Zeller T, Jaff MR. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. 2014 May 1;83(6):E212-20. doi: 10.1002/ccd.25387. Epub 2014 Feb 10.
- Background: PubMed 27369975Okuno 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.
- Background: PubMed 30862415He 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.
- Background: PubMed 26250747Tepe G, Beschorner U, Ruether C, Fischer I, Pfaffinger P, Noory E, Zeller T. Drug-Eluting Balloon Therapy for Femoropopliteal Occlusive Disease: Predictors of Outcome With a Special Emphasis on Calcium. J Endovasc Ther. 2015 Oct;22(5):727-33. doi: 10.1177/1526602815600156. Epub 2015 Aug 6.
- Background: PubMed 30562083Cassese S, Wolf F, Ingwersen M, Kinstner CM, Fusaro M, Ndrepepa G, Ibrahim T, Ott I, Lammer J, Krankenberg H, Fusaro M. Drug-Coated Balloon Angioplasty for Femoropopliteal In-Stent Restenosis. Circ Cardiovasc Interv. 2018 Dec;11(12):e007055. doi: 10.1161/CIRCINTERVENTIONS.118.007055.
- Background: PubMed 31204595Chen Z, Guo W, Jiang W, Wang F, Fu W, Zou Y, Deckers S, Li P, Popma JJ, Jaff MR. IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population. J Endovasc Ther. 2019 Aug;26(4):471-478. doi: 10.1177/1526602819852084. Epub 2019 Jun 17.
- Background: PubMed 31126769Caradu 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.
- Background: PubMed 31006305Brodmann 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.
- Background: PubMed 32242768Adams G, Shammas N, Mangalmurti S, Bernardo NL, Miller WE, Soukas PA, Parikh SA, Armstrong EJ, Tepe G, Lansky A, Gray WA. Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study. J Endovasc Ther. 2020 Jun;27(3):473-480. doi: 10.1177/1526602820914598. Epub 2020 Apr 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziheng Wu, M.D. principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoropopliteal Artery Occlusion, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziheng Wu, M.D. (0571-87236648, wuziheng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04716361, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.