Peripheral Arterial Disease Trial, Recruiting NCT04885985 Sponsor: Acotec Scientific Co., Ltd Condition: Peripheral Arterial Disease
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Peripheral Arterial Disease Trial, Recruiting

NCT04885985
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 aged 18 to 75 years old
  • People with a leg circulation problem rated at Rutherford category 3, 4, or 5 — meaning moderate to severe symptoms such as leg pain at rest or small wounds that won't heal (confirm with trial site)
  • People who have a significant narrowing (70% or more) or a blockage in an artery below the knee, either new or previously treated, where blood flow beyond the blockage is still open
  • People whose affected artery measures between 2 mm and 4 mm in diameter
  • People who have given written consent, understand the purpose of the trial, and agree to attend all required check-ups and follow-up visits

Who may not be able to join:

  • People whose kidneys are not filtering blood well enough (creatinine clearance below 30 mL/min)
  • People who have a sudden, new blockage or blood clot in the artery being treated
  • People who are already scheduled to have a limb amputation on the leg being treated
  • People who are completely confined to bed and unable to walk at all
  • People who have had a clot-dissolving treatment or surgery on the affected leg within the 6 weeks before joining
  • People whose life expectancy is estimated to be less than 5 years
  • People whose total length of complete blockages in the target artery adds up to more than 150 mm
  • People who have a blockage inside a previously placed stent in the target area, or whose blockage is within 20 mm of an existing stent
  • People who have had a stroke in the 90 days before joining
  • People with a known allergy to contrast dye (used in imaging), blood-thinning medications, or clot-dissolving medications
  • People with a bleeding disorder that cannot be corrected
  • People where a complete blockage in a specific section of the artery behind the knee (the P3 segment of the popliteal artery) prevents doctors from identifying blood flow into the treated area (confirm with trial site)
  • People who are pregnant or breastfeeding
  • People whose blockage cannot be crossed with a guidewire during the procedure (confirm with trial site)
  • People who are currently participating in another clinical trial of a medical device or drug

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 23 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: Zhuang Baixi, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Phone: 010-62835122

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

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Acotec Scientific Co., Ltd
Registry
ClinicalTrials.gov
Start date
31 December 2021
Est. completion
1 August 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Primary Patency

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: 23 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