Peripheral Arterial Disease Trial, Recruiting NCT05620095 Sponsor: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology Condition: Peripheral Arterial Disease
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Peripheral Arterial Disease Trial, Recruiting

NCT05620095
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been assessed as having a Rutherford grade 4, 5, or 6 — a medical rating that indicates serious reduced blood flow to the legs, causing rest pain, ulcers, or gangrene (confirm with trial site)
  • People who understand the study's purpose, are willing to take part, sign a consent form, and agree to attend follow-up appointments
  • People who have one or more blockages or narrowings (70% or more narrowing, or full blockage) in the arteries below the knee, where the affected area is longer than 20mm and does not extend past the ankle joint
  • People whose blocked artery was successfully crossed with a guidewire during the procedure, and where blood flow was confirmed to be running continuously after balloon treatment
  • People who had at least one artery below the knee treated with a drug-coated balloon
  • People who also have blockages in the upper leg or pelvic arteries, where those blockages were successfully treated first, leaving less than 50% narrowing remaining
  • People who had a blood clot in a leg artery that was treated with clot-removal procedures before receiving drug-coated balloon treatment below the knee
  • People who had both legs treated with a drug-coated balloon may be enrolled, with each leg recorded according to its treatment time
  • People with a life expectancy of more than 24 months

Who may not be able to join:

  • People in whom blood flow could not be successfully restored during the procedure
  • People who have had a stroke, brain bleed, gastrointestinal bleed, or heart attack within the 3 months before enrolling
  • People who are known to be allergic to heparin, aspirin, other blood-thinning medications, contrast dye, or similar substances
  • People who have taken part in another clinical trial for a drug or medical device in the 3 months before enrolling, where that trial could interfere with this one
  • People who are pregnant or breastfeeding
  • People who have Buerger's disease (a condition affecting blood vessels in the limbs)
  • People whose limb infection or severe lack of blood flow means a major amputation is considered necessary before the procedure

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Zibo Feng, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

Phone: 86-13545160302

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Registry
ClinicalTrials.gov
Start date
1 December 2020
Est. completion
1 November 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Primary sustained clinical improvement at 12 months post-procedure; Freedom of major limb adverse events at 12 months post-procedure

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov