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New catheter delivers drug directly to leg arteries to prevent reblockage

NCT ID NCT00821028

Disease control Sponsor: University of Oklahoma 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 pilot study tested whether delivering the drug paclitaxel directly to the leg artery during angioplasty could reduce the chance of the artery narrowing again. 27 adults with leg pain from blocked arteries took part. The main goal was to see if the drug helped keep the artery open longer than standard treatment alone.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

27 people

The number who actually took part.

Start date

Jan 2009

Finished

Apr 2012

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.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * All subjects between 18 and 80 years of age with symptomatic claudication (Rutherford category 1-6) with TASC II type A, B, or C lesions will be invited to participate (23, 24). * Patients must be on appropriate pharmacologic therapy for PAD including antiplatelet agents and lipid-lowering therapy. Exclusion Criteria: * Life expectancy \<1year * Acute limb ischemia * Anatomy not amenable to percutaneous revascularization * Inability to provide informed consent * Renal insufficiency (creatinine clearance \<40mL/min calculated using Cockcroft-Gault equation) * Prisoners * Pregnant or lactating women

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Conditions

The condition(s) this trial relates to.

atherosclerosis peripheral arterial disease

As listed by the trial registrant

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

Angioplasty Atherosclerosis Peripheral arterial disease

Contacts and locations

Locations

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73126, United States

More trials for these conditions

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