Infrapopliteal Artery Occlusive DiseaseNCT06009146
Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease.
An observational study of Infrapopliteal Artery Occlusive Disease and Endovascular Treatment, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study is a prospective, multi-center observational study, which evaluates the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infrapopliteal Artery Occlusive Disease, Endovascular Treatment
- What is being tested?
- Endovascular treatment
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Oct 2025
- 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: Patients with infrapopliteal arterial occlusive disease undergoing endovascular treatment.
Who may be able to join
- 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;
Who cannot join
- 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；
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Xixiang Gao, M.D., +8613581674309, vascsurgeon@163.com
About this study
Official title: Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease: a Prospective, Multicenter, Real-world Study
This study is a prospective, multi-center observational study, which evaluates the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.
Read the detailed description
This study is a prospective, multi-center observational study. This study will be conducted at 38 centers and is expected to enroll more than 3000 patients. And we will evaluate the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.
- Being tested
- Endovascular treatment
- Keywords
- Endovascular Treatment, Infrapopliteal Artery Disease, Drug-coated Balloons, Angioplasty, Atherectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatmentDevice
Endovascular treatment for infrapopliteal arterial disease.
| Study group | Role | What they receive |
|---|---|---|
| Rutherford scale < 4 | Not described Receives: Device: Endovascular treatment | |
| Rutherford scale 4-5 | Not described Receives: Device: Endovascular treatment | |
| Rutherford scale 6 | Not described Receives: Device: Endovascular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major adverse event rate
Major adverse events include Death, major amputation rates and clinical driven target lesion revascularization (CDTLR).
Measured: 12 months
Secondary outcomes (9)
Amputation-free survival
Freedom from death and major amputation
Measured: 12 months
Survival
Freedom from all-cause mortality.
Measured: 12 months
Freedom from major amputation
Freedom from major amputation
Measured: 12 months
Freedom from CDTLR
Freedom from clinical driven target lesion revascularization
Measured: 12 months
Freedom from clinical driven target limb revascularization
Freedom from clinical driven target limb revascularization
Measured: 12 months
Rutherford categories
Rutherford categories
Measured: 12 months
Wound condition
Wound and foot infections were scored using WIfI system.
Measured: 12 months
Complication rates
Minor and Major complications rates.
Measured: 1 week
Quality of life score
Vascular quality of life questionnaire was used.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Jul 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infrapopliteal Artery Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Peking University First Hospital, Beijing Hospital, Chengdu University of Traditional Chinese Medicine, The First Affiliated Hospital of Dalian Medical University, Huashan Hospital, Shanghai Pudong Hospital, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Guangzhou Medical University, Changhai Hospital, Hebei General Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, LanZhou University, The Second Hospital University of South China, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Affiliated Hospital of Qingdao University, Qingdao Haici Hospital, Beijing Tsinghua Changgeng Hospital, First Hospital of Tsinghua University, Shanxi Provincial People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, RenJi Hospital, The Luhe Teaching Hospital of the Capital Medical University, Beijing Friendship Hospital, Second Affiliated Hospital of Soochow University, Tianjin First Central Hospital, Tianjin Medical University General Hospital, Renmin Hospital of Wuhan University, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital of Xinjiang Medical University, Zhejiang University, The First Affiliated Hospital of Zhengzhou University, Chinese Academy of Medical Sciences, Fuwai Hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Xiangya Hospital of Central South University, First Affiliated Hospital of Chongqing Medical University
- Responsible party
- Sponsor
- Investigators
- Lianrui Guo, M.D., Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009146
- Sponsor's protocol ID
- IPOD-Real Study
- Status last verified
- Aug 2023
- First submitted
- 20 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease: a Prospective, Multicenter, Real-world Study
- ClinicalTrials.gov ID
- NCT06009146
- Acronym / sponsor ID
- IPOD-Real Study
- Keywords
- Endovascular Treatment, Infrapopliteal Artery Disease, Drug-coated Balloons, Angioplasty, Atherectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Peking University First Hospital, Beijing Hospital, Chengdu University of Traditional Chinese Medicine, The First Affiliated Hospital of Dalian Medical University, Huashan Hospital, Shanghai Pudong Hospital, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Guangzhou Medical University, Changhai Hospital, Hebei General Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, LanZhou University, The Second Hospital University of South China, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Affiliated Hospital of Qingdao University, Qingdao Haici Hospital, Beijing Tsinghua Changgeng Hospital, First Hospital of Tsinghua University, Shanxi Provincial People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, RenJi Hospital, The Luhe Teaching Hospital of the Capital Medical University, Beijing Friendship Hospital, Second Affiliated Hospital of Soochow University, Tianjin First Central Hospital, Tianjin Medical University General Hospital, Renmin Hospital of Wuhan University, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital of Xinjiang Medical University, Zhejiang University, The First Affiliated Hospital of Zhengzhou University, Chinese Academy of Medical Sciences, Fuwai Hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Xiangya Hospital of Central South University, First Affiliated Hospital of Chongqing Medical University
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 24 Aug 2023 (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, multi-center observational study, which evaluates the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.
Detailed description
This study is a prospective, multi-center observational study. This study will be conducted at 38 centers and is expected to enroll more than 3000 patients. And we will evaluate the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rutherford scale < 4 | – | Device: Endovascular treatment |
| Rutherford scale 4-5 | – | Device: Endovascular treatment |
| Rutherford scale 6 | – | Device: Endovascular treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with infrapopliteal arterial occlusive disease undergoing endovascular treatment.
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (1 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular treatmentEndovascular treatment for infrapopliteal arterial disease. | Device | Rutherford scale 4-5, Rutherford scale 6, Rutherford scale < 4 |
Primary outcome
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).
9 secondary outcomes
Amputation-free survival
Time frame: 12 months
Survival
Time frame: 12 months
Freedom from major amputation
Time frame: 12 months
Freedom from CDTLR
Time frame: 12 months
Freedom from clinical driven target limb revascularization
Time frame: 12 months
Rutherford categories
Time frame: 12 months
Wound condition
Time frame: 12 months
Complication rates
Time frame: 1 week
Quality of life score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
Lianrui Guo, M.D. study chair
Xuanwu Hospital, Beijing
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 Infrapopliteal Artery Occlusive Disease and Endovascular Treatment, run by Xuanwu Hospital, Beijing 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 1 inclusion and 1 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 24 Aug 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 Lianrui Guo, M.D. (+8613671009746, lianruiguo@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from major adverse event rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2023.