An observational study in Chronic Limb Threatening Ischemia, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Observational
Among 23 studies in Chronic Limb-Threatening Ischemia with a site in China — 7 open to participants now, 7 under way, none of them phase 3. Chronic Limb-Threatening Ischemia · China.
Among the 23 studies in Chronic Limb-Threatening Ischemia with a site in China, this one is one of 2 that started in 2025, is one of 8 observational ones, and was the 20th registered.
357 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 72 are open to participants now.
Browse Chronic Limb-Threatening Ischemia studies →7 of the 23 studies in Chronic Limb-Threatening Ischemia with a site in China are open now. Recruiting first, the newest first:
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology · Sites in China
Ages 18+
Allife Medical Science and Technology Co., Ltd. · Sites in China
Ages 18–80
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology · Sites in China
Ages 18+
Beijing Northland Biotech. Co., Ltd. · Sites in China
Ages 20–85
Beijing Tsinghua Chang Gung Hospital · Sites in China
Ages 18+ · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 49 Chronic Limb-Threatening Ischemia studies recruiting now, 33 (67%) set no upper age limit and 2 (4%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 4 · Phase 3 2 · Phase 4 4
First in 2010; this study’s year is marked. 2 started in 2025.
This study's planned enrollment of 700 is above the median of 111 across 102 observational studies indexed under Chronic Limb-Threatening Ischemia.
Median enrollment 120 across the 15 interventional studies, 336 across the 8 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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7 of 23 have an industry lead sponsor. The 10 most frequent:
First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 162 studies on the registry; 54 are open to participants now.
First Affiliated Hospital, Sun Yat-Sen University has 1 study filed under Chronic Limb-Threatening Ischemia — fewer than ten, so there is no comparison to draw.
1 of the studies in Chronic Limb-Threatening Ischemia with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06713850Liyuan Hospital of Tongji Medical College, Huazhong University of Science and TechnologyAngioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions | 2027-11 |
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Among the 23 studies in Chronic Limb-Threatening Ischemia with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a prospective, multicenter, observational study designed to evaluate the clinical outcomes of the Ranger™ SL paclitaxel-coated balloon, a type of drug-coated balloon (DCB), in the treatment of below-the-knee (BTK) lesions in patients with chronic limb-threatening ischemia (CLTI) in China. All enrolled patients will be followed for six months. Patients diagnosed with CLTI who undergo treatment with the Ranger DCB will be included in the study. The primary outcome is the incidence of major adverse events (MAEs).
Patients with below-the-knee (BTK) arterial lesions diagnosed with chronic limb-threatening ischemia (CLTI).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Gangrene involving any part of the lower extremities or feet, with exclusion of patients who have:
4.1 Pure venous ulcers 4.2 Pure traumatic wounds 4.3 Acute limb ischemia (symptoms present for 2 weeks or less) 4.4 Embolic disease 4.5 Non-atherosclerotic chronic lower extremity vascular diseases (e.g., vasculitis, Buerger's disease, radiation arteritis)
6.1 Unobstructed blood flow in the suprapopliteal access pathway (including inflow vessels that have been recanalized via staged or concurrent endovascular intervention or hybrid surgery).
6.2 Sub-knee stenotic lesions ≥ 5 cm in length with ≥ 70% diameter reduction. 6.3 Sub-knee occlusive lesions ≥ 1 cm in length. 6.4 Two separate lesions with a minimum 3 cm interval between them may be considered as a single lesion for study inclusion purposes.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ranger drug-coated balloon group
Device: drug-coated balloon
Drug-coated balloon was used during the index procedure.
Major Adverse Events (MAEs)
Composite of target lesion revascularization (TLR), target limb amputation, and all-cause mortality.
Time frame: 1 month; 3 months; 6 months
Late Lumen Loss (LLL)
Late lumen loss at the target lesion, measured by Quantitative Vascular Angiography (QVA).
Time frame: 1 month; 3 months; 6 months
Postoperative Complications
Incidence of procedure-related adverse events, including arterial dissection, perforation, rupture, distal embolization, acute thrombosis, pseudoaneurysm, and hematoma formation.
Time frame: During procedure and hospitalization (up to 7 days post-procedure)
Quality of Life (QoL)
Assessed using the VascuQol-25 questionnaire, scored on a scale from 1 (worst) to 7 (best). Quality-adjusted life years (QALYs) calculated by multiplying the health-related quality of life (HRQoL) index score by time spent in each health state.
Time frame: Baseline, 1 month; 3 months; 6 months
Rutherford Classification
Grading system (0-6) for evaluating the severity of peripheral artery disease (PAD) in the lower extremities.
Time frame: Baseline, 1 month; 3 months; 6 months
Amputation-Free Survival (AFS)
Defined as survival without ipsilateral major amputation (above the ankle).
Time frame: 1 month; 3 months; 6 months
Limb Salvage
Freedom from major (above-ankle) amputation in the target limb.
Time frame: 1 month; 3 months; 6 months
Plan to share: No
Start is estimated for Jun 2025; primary completion for Jun 2028, 36 months later.
Of 46 non-industry observational studies under Chronic Limb-Threatening Ischemia, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 60. This study's planned 36 months is below that.
Counting every sponsor, half of 51 studies reached it within 34 months; a quarter within 22 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Chronic Limb-Threatening Ischemia →
First Affiliated Hospital, Sun Yat-Sen University →