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New study tests ways to fix blocked leg stents

NCT ID NCT04801004

Disease control Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looked at different treatments for people whose leg artery stents had become completely blocked. It included 322 adults with severe leg pain or wounds. The goal was to see how well the treatments restored blood flow and how long it lasted without needing another procedure.

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.

Participants

322 people

The number who actually took part.

Started

Apr 2021

Finished

Mar 2026

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

The patients with Tosaka III in-stent restenosis lower extremity femoropopliteal artery.

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: 1. Tosaka III In-stent restenosis after stent implantation in PAD patients (Including acute and subacute thrombotic lesions). 2. Rutherford grade 2-5. 3. Stents should be located in the femoropopliteal artery. 4. The stenosis of iliac artery on the affected side is less than 30% or the residual stenosis after treatment is less than 30%. 5. Informed consent has been signed Exclusion Criteria: 1. Tosaka I or II in-stent restenosis. 2. Stents are located in iliac artery or artery below the knee, or the preoperative CTA showed type 3 or 4 stent fracture. 3. Rutherford Grade 6. 4. Thromboangiitis obliterans (TAO)-based, arteritis-based or connective tissue disorder-based FP-ISR. 5. Intraoperative conversion to hybrid or open surgery. 6. Patients refusing to sign informed consent forms. 7. Life expectancy of patients is less than 12 months. 8. The pregnant or nursing patients. 9. The patients with severe ischemia of lower extremity who would receive major amputation in plan. 10. Patients in whom antiplatelet or anticoagulant therapy is contraindicated. 11. Myocardial infarction or stroke within 3 months prior to enrolment. 12. Patient with known allergy to contrast agents or medications used to perform endovascular intervention. 13. Patients participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint. 14. Patients who refuse to cooperate with long-term follow-up or who have difficulty communicating.

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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

  • Zhongshan Hospital, Fudan University

    Shanghai, China

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