Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease.
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ClinicalTrials.gov Identifier: NCT06009146 |
Recruitment Status :
Recruiting
First Posted : August 24, 2023
Last Update Posted : August 24, 2023
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Condition or disease | Intervention/treatment |
---|---|
Infrapopliteal Artery Occlusive Disease Endovascular Treatment | Device: Endovascular treatment |
Study Type : | Observational |
Estimated Enrollment : | 3000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease: a Prospective, Multicenter, Real-world Study |
Actual Study Start Date : | July 1, 2023 |
Estimated Primary Completion Date : | October 1, 2024 |
Estimated Study Completion Date : | October 1, 2025 |
Group/Cohort | Intervention/treatment |
---|---|
Rutherford scale < 4 |
Device: Endovascular treatment
Endovascular treatment for infrapopliteal arterial disease. |
Rutherford scale 4-5 |
Device: Endovascular treatment
Endovascular treatment for infrapopliteal arterial disease. |
Rutherford scale 6 |
Device: Endovascular treatment
Endovascular treatment for infrapopliteal arterial disease. |
- Freedom from major adverse event rate [ Time Frame: 12 months ]Major adverse events include Death, major amputation rates and clinical driven target lesion revascularization (CDTLR).
- Amputation-free survival [ Time Frame: 12 months ]Freedom from death and major amputation
- Survival [ Time Frame: 12 months ]Freedom from all-cause mortality.
- Freedom from major amputation [ Time Frame: 12 months ]Freedom from major amputation
- Freedom from CDTLR [ Time Frame: 12 months ]Freedom from clinical driven target lesion revascularization
- Freedom from clinical driven target limb revascularization [ Time Frame: 12 months ]Freedom from clinical driven target limb revascularization
- Rutherford categories [ Time Frame: 12 months ]Rutherford categories
- Wound condition [ Time Frame: 12 months ]Wound and foot infections were scored using WIfI system.
- Complication rates [ Time Frame: 1 week ]Minor and Major complications rates.
- Quality of life score [ Time Frame: 12 months ]Vascular quality of life questionnaire was used.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Patients ≥ 18 years of age; Patients with ≥1 infrapopliteal artery disease (P3 popliteal artery, anterior tibial artery, posterior tibial artery, peroneal artery, tibiofibular trunk) need to receive endovascular treatment, regardless of whether there is a combination of supra-knee or submalleolar occlusion; Patients voluntary and capable of follow-up;
Exclusion Criteria:
Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc., and those who are unable to undergo endovascular therapy for other reasons; Pregnant and lactating women; Patients with thromboangiitis obliterans;
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06009146
Contact: Lianrui Guo, M.D. | +8613671009746 | lianruiguo@sina.com | |
Contact: Xixiang Gao, M.D. | +8613581674309 | vascsurgeon@163.com |
China, Beijing | |
Xuanwu Hospital, Capital Medical University | Recruiting |
Beijing, Beijing, China, 100053 | |
Contact: Xixiang Gao, M.D. +8613581674309 vascsurgeon@163.com |
Study Chair: | Lianrui Guo, M.D. | Xuanwu Hospital, Beijing |
Responsible Party: | Xuanwu Hospital, Beijing |
ClinicalTrials.gov Identifier: | NCT06009146 |
Other Study ID Numbers: |
IPOD-Real Study |
First Posted: | August 24, 2023 Key Record Dates |
Last Update Posted: | August 24, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Endovascular Treatment Infrapopliteal Artery Disease Drug-coated Balloons Angioplasty Atherectomy |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |