Peripheral Arterial Disease Trial, Recruiting NCT04511247 Sponsor: Concept Medical Inc. Condition: Peripheral Arterial Disease
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Peripheral Arterial Disease Trial, Recruiting

NCT04511247
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 21 years or older
  • People who have a serious limb condition rated as Rutherford class 4 to 6 — this means the affected leg has rest pain, non-healing wounds, or tissue loss (confirm with trial site)
  • People whose leg artery blockage or narrowing (greater than 50% narrowed or fully blocked) is located in the upper portion of the arteries below the knee, with the affected area measuring between 2 and 20 centimetres
  • People whose arteries leading into the affected area are either clear, or were successfully cleared (to less than 30% narrowing) before or during the procedure
  • People whose treated artery has confirmed blood flow continuing through to the foot after the procedure

Who may not be able to join:

  • People whose overall health conditions mean their life expectancy is estimated at one year or less
  • People currently taking part in another clinical trial for an unapproved drug or device that has not yet reached its main result stage
  • People who are pregnant or planning to become pregnant during the study period
  • People who have gangrene affecting the heel
  • People who have previously had bypass surgery on the artery being treated in this trial
  • People for whom amputation of the affected leg is already planned
  • People who have a previously implanted stent in the artery area being treated
  • People who are considered vulnerable or legally protected adults (confirm with trial site)
  • People who have a bleeding disorder, or a condition such as a stomach ulcer, that prevents safe use of the blood-thinning medications clopidogrel or aspirin
  • People with a known allergy to the drug sirolimus
  • People in whom a guidewire could not be successfully passed through the blocked artery during the procedure
  • People whose artery blockage extends beyond the ankle joint
  • People in whom a pre-existing narrowing in a nearby artery could not be reduced to less than 30% during the procedure
  • People whose artery could only be accessed from a reverse direction approach (a technique called SAFARI)
  • People whose artery blockage involves heavy calcium deposits running continuously on both sides of the blockage
  • People whose procedure required the use of drug-coated balloons, drug-eluting stents, specialty balloons, or plaque-removal devices

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 28 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: Edward Choke, Sengkang General Hospital

Phone: +65 69302164

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
Concept Medical Inc.
Registry
ClinicalTrials.gov
Start date
15 August 2020
Est. completion
1 December 2026

Where this trial is recruiting

🇸🇬 Singapore 🇹🇼 Taiwan 🇹🇭 Thailand

Primary endpoints

Primary patency at 6 months

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: 28 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