Chronic Limb-threatening IschemiaNCT04710420
Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With Wound, Ischemia, and Foot Infection (WIFI) Assessment
An observational study of Chronic Limb-threatening Ischemia and Endovascular Therapy, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This is a prospective multicenter clinical study that used WIFI grading scores at different periods to evaluate the therapeutic value of endovascular therapy and this grading system for Chronic limb-threatening ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Limb-threatening Ischemia, Endovascular Therapy
- What is being tested?
- Endovascular therapy
- Type of treatment
- Medical device
- How many people
- 842 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Jun 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: Patients with Chronic limb-threatening ischemia.
Who may be able to join
- patients > 18 years of age;
- patients with Chronic limb-threatening ischemia (CLTI);
- patients with below-the-knee lesions undergoing endovascular treatment;
- target limbs with certain WIfI stage;
- patients voluntary and capable of follow-up;
- informed consent.
- Definition of CLTI:
- A diagnosis of CLTI requires objectively documented atherosclerotic PAD in association with ischemic rest pain or tissue loss (ulceration or gangrene).
Who cannot join
- Contraindication for antiplatelet , anticoagulant or thrombolytic agent;
- Contrast agent allergy;
- Dysfunctional protein C, protein S, antithrombin Ⅲ(AT Ⅲ) or refusal of blood transfusion;
- Complications affecting surgical safety;
- Major amputation was adopted to the target extremity;
- The existence of aneurysm in the target vessels;
- The existence of perforation, dissection or any other injury requiring intervention in the target vessels.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With WIFI Assessment
This is a prospective multicenter clinical study that used WIFI grading scores at different periods to evaluate the therapeutic value of endovascular therapy and this grading system for Chronic limb-threatening ischemia.
- Being tested
- Endovascular therapy
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular therapyDevice
Endovascular treatment for critical limb threatening Ischemia
| Study group | Role | What they receive |
|---|---|---|
| WIfI stage 1 | Very low risk of amputation was determined according to the SVS WIfI classification system. Receives: Device: Endovascular therapy | |
| WIfI stage 2 | Low risk of amputation was determined according to the SVS WIfI classification system. Receives: Device: Endovascular therapy | |
| WIfI stage 3 | Moderate risk of amputation was determined according to the SVS WIfI classification system. Receives: Device: Endovascular therapy | |
| WIfI stage 4 | High risk of amputation was determined according to the SVS WIfI classification system. Receives: Device: Endovascular therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major amputation
Major amputation was defined as any amputation above-the-ankle of the target limb.
Measured: 12 months
Secondary outcomes (10)
WIfI stages
Before follow-up and during each follow-up, the Society for Vascular Surgery wound, ischemia, and foot Infection (WIfI) were evaluated classification system.
Measured: 12 months
Amputation-free survival
Survival without target limb major amputation.
Measured: 12 months
Freedom from all-cause death
Freedom from all-cause death.
Measured: 12 months
Freedom from clinically driven target limb reintervention
Clinically driven target limb reintervention was defined as any reintervention of ipsilateral infrapopliteal arteries for recurrent clinical symptoms.
Measured: 12 months
Freedom from major adverse event
Major adverse event was a composite of major amputation, all-cause death, and clinically driven target limb reintervention.
Measured: 12 months
Quality of life
The Vascular Quality of Life (VascuQol) questionnaire was used to assess QOL score.
Measured: 12 months
Primary sustained clinical improvement
A decrease of at least 1 Rutherford grade without any reintervention.
Measured: 12 months
Hospitalization time
The length of hospital stay was evaluated
Measured: 12 months
Hospitalization expenses
Hospitalization costs for patients were evaluated
Measured: 12 months
Adverse event rates
Adverse event rates includes surgically related arterial dissection, perforation, rupture, embolism, acute thrombosis, pseudoaneurysm and hematoma formation
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Dec 2020
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Limb-threatening IschemiaStudies 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
- 842 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Zhejiang University, First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital of Soochow University, Qingdao Haici Hospital, Chengdu University of Traditional Chinese Medicine, Fudan University, Huashan Hospital
- Responsible party
- Principal investigator, Lian-Rui Guo, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710420
- Sponsor's protocol ID
- PRIME-WIFI
- Status last verified
- Jul 2024
- First submitted
- 8 Jan 2021
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With WIFI Assessment
- ClinicalTrials.gov ID
- NCT04710420
- Acronym / sponsor ID
- PRIME-WIFI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 842 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- RenJi Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Zhejiang University, First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital of Soochow University, Qingdao Haici Hospital, Chengdu University of Traditional Chinese Medicine, Fudan University, Huashan Hospital
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 14 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 is a prospective multicenter clinical study that used WIFI grading scores at different periods to evaluate the therapeutic value of endovascular therapy and this grading system for Chronic limb-threatening ischemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| WIfI stage 1 | – | Device: Endovascular therapyVery low risk of amputation was determined according to the SVS WIfI classification system. |
| WIfI stage 2 | – | Device: Endovascular therapyLow risk of amputation was determined according to the SVS WIfI classification system. |
| WIfI stage 3 | – | Device: Endovascular therapyModerate risk of amputation was determined according to the SVS WIfI classification system. |
| WIfI stage 4 | – | Device: Endovascular therapyHigh risk of amputation was determined according to the SVS WIfI classification system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic limb-threatening ischemia.
Key inclusion criteria (8 listed)
- patients > 18 years of age;
- patients with Chronic limb-threatening ischemia (CLTI);
- patients with below-the-knee lesions undergoing endovascular treatment;
- target limbs with certain WIfI stage;
- patients voluntary and capable of follow-up;
Key exclusion criteria (7 listed)
- Contraindication for antiplatelet , anticoagulant or thrombolytic agent;
- Contrast agent allergy;
- Dysfunctional protein C, protein S, antithrombin Ⅲ(AT Ⅲ) or refusal of blood transfusion;
- Complications affecting surgical safety;
- Major amputation was adopted to the target extremity;
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 therapyEndovascular treatment for critical limb threatening Ischemia | Device | WIfI stage 1, WIfI stage 2, WIfI stage 3, WIfI stage 4 |
Primary outcome
Freedom from major amputation
Time frame: 12 months
Major amputation was defined as any amputation above-the-ankle of the target limb.
10 secondary outcomes
WIfI stages
Time frame: 12 months
Amputation-free survival
Time frame: 12 months
Freedom from all-cause death
Time frame: 12 months
Freedom from clinically driven target limb reintervention
Time frame: 12 months
Freedom from major adverse event
Time frame: 12 months
Quality of life
Time frame: 12 months
Primary sustained clinical improvement
Time frame: 12 months
Hospitalization time
Time frame: 12 months
Hospitalization expenses
Time frame: 12 months
Adverse event rates
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Limb-threatening Ischemia and Endovascular Therapy, 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 9 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from major amputation (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 9 Jul 2024.