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Shockwave stent trial pulled before it began

NCT ID NCT05147363

Disease control Sponsor: Cardiovascular Institute of the South Clinical Research Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study planned to test a special shockwave device that uses sound waves to crack calcium buildup in leg arteries before placing a stent. The goal was to improve stent fit and long-term blood flow in people with severe peripheral artery disease. However, the trial was withdrawn before enrolling any participants, so no data was collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Shockwave Intravenous Lithotripsy device with a Supera stent
What this could lead to
If it had worked, this approach could have improved stent success and long-term blood flow in leg arteries, reducing the need for repeat procedures.
What could go wrong
The trial was withdrawn before any participants were enrolled, so no results are available. The procedure also carries risks like vessel injury or heart events.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Started

Dec 2020

Finished

Jul 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

50 consented adults 18 years of age or older, identified to have de novo, severely calcified femoral popliteal arteries requiring revascularization

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * age ≥ 18 years * Treatment for de novo, densely calcified femoral popliteal arteries with 70-100% stenosis as measured by IVUS. * Lesion lengths up to 140 mm. * Planned follow-up within the health clinic. Exclusion Criteria: * Calcified femoral popliteal arteries that show \<70% stenosis by angiography. * Calcified femoral popliteal arteries with 100% stenosis in which the lesion cannot be crossed after pre-dilation with a 2-3mm balloon. * Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension). * Thrombophlebitis or deep venous thrombus, within the previous 30 days. * Evidence of end stage renal disease (ESRD) or stage 5 chronic kidney disease (CKD). * Currently receiving treatment in an investigational device or drug study or anticipate participating in an investigational device or drug study for the duration of this study. * Anticipated life expectancy less than 6 months. * Lack of phone or email for contact.

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral arterial disease

Contacts and locations

Locations

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.