Peripheral Arterial Disease Trial, Recruiting NCT05145478 Sponsor: Yale University Condition: Peripheral Arterial Disease
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Peripheral Arterial Disease Trial, Recruiting

NCT05145478
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:

  • You have leg pain when walking or more serious leg problems due to poor blood flow (classified at a certain level of severity by your doctor)
  • You are considered a suitable candidate for a procedure that uses X-ray imaging to look at your blood vessels and for a minimally invasive treatment
  • You are scheduled to have a specific procedure called Shockwave Intravascular Lithotripsy (a treatment that uses sound waves to break up hardened deposits in blood vessels), followed by another standard treatment chosen by your doctor
  • The blocked or narrowed area being treated is in a specific artery in your groin/upper leg that has not been treated before
  • The blood vessel being treated measures between 4.0mm and 7.0mm wide (estimated by the doctor)
  • The narrowing in the vessel is at least 70% blocked, as estimated by the doctor
  • The length of the narrowed area is no more than 50mm (about 2 inches)
  • If the vessel is completely blocked, that blocked section is also no longer than 50mm
  • The vessel has at least a moderate amount of calcium buildup, visible on imaging, meeting specific size requirements (confirm with trial site)

Who may not be able to join:

  • You have a medical condition that makes you unsuitable for the Shockwave treatment device, based on the device instructions or your doctor's judgment
  • You are already taking part in another research study that could affect the results of this trial
  • You have a documented cognitive impairment (such as a condition affecting memory or thinking)
  • You do not speak English or Spanish
  • You are currently in prison
  • You are pregnant or breastfeeding
  • Your doctor estimates you have less than 12 months to live at the time of screening
  • You have previously had a surgical procedure to clear out the same artery in your groin that would be treated in this trial

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 2 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.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
1 December 2021
Est. completion
1 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Generic Health Status; Change in Generic Health Status; Rate of Procedural Success

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: 2 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