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Peripheral Arterial DiseaseFP-RestoreNCT04801004

A Real-world Study to Evaluate the Primary Patency and Freedom From TLR of Endovascular Treatment in TOSAKA III In-stent Restenosis of Lower Extremity Femoropopliteal Artery.

An observational study of Peripheral Arterial Disease, run by Shanghai Zhongshan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a prospective, multi-center, real world, observational study, which aims at evaluating the safety, efficacy and economic cost of endovascular treatments for endovascular therapies in tosaka III (totally occluded) in-stent restenosis.It is estimated that 300 subjects diagnosed with tosaka III in-stent… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
How many people
322 participants
Where
1 siteChina
Study dates
1 Apr 2021to 1 Mar 2026
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • Tosaka III In-stent restenosis after stent implantation in PAD patients (Including acute and subacute thrombotic lesions).
  • Rutherford grade 2-5.
  • Stents should be located in the femoropopliteal artery.
  • The stenosis of iliac artery on the affected side is less than 30% or the residual stenosis after treatment is less than 30%.
  • Informed consent has been signed

Who cannot join

  • Tosaka I or II in-stent restenosis.
  • Stents are located in iliac artery or artery below the knee, or the preoperative CTA showed type 3 or 4 stent fracture.
  • Rutherford Grade 6.
  • Thromboangiitis obliterans (TAO)-based, arteritis-based or connective tissue disorder-based FP-ISR.
  • Intraoperative conversion to hybrid or open surgery.
  • Patients refusing to sign informed consent forms.
Show all 14Show fewer
  • Life expectancy of patients is less than 12 months.
  • The pregnant or nursing patients.
  • The patients with severe ischemia of lower extremity who would receive major amputation in plan.
  • Patients in whom antiplatelet or anticoagulant therapy is contraindicated.
  • Myocardial infarction or stroke within 3 months prior to enrolment.
  • Patient with known allergy to contrast agents or medications used to perform endovascular intervention.
  • Patients participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
  • Patients who refuse to cooperate with long-term follow-up or who have difficulty communicating.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Hospital, Fudan University

    Shanghai

Other trials in China

About this study

This study is a prospective, multi-center, real world, observational study, which aims at evaluating the safety, efficacy and economic cost of endovascular treatments for endovascular therapies in tosaka III (totally occluded) in-stent restenosis.It is estimated that 300 subjects diagnosed with tosaka III in-stent restenosis and receive endovascular treatments will be enrolled in nine centers from April 2021 to December 2022 nation-widely. All the subjects will be under follow-up for 24 months. There is no restriction on the endovascular techniques. The primary outcomes include clinical-driven freedom from TLR at 24 months.

Read the detailed description

In-stent restenosis was a series of complications of treatment in peripheral artery disease, which lead the fluid of lower extremity re-limited even chronic limb ischemia and amputation. Its typical symptoms were recurrent claudication, rest pain and ischemic. Tosaka III in-stent restenosis, which also called in-stent occlusion was one of the most serious of this kind of complications. Its symptoms usually more severe and irreversible, and its treatments were complicated and challenging. The efficacy of single balloon angioplasty is limited. New devices including drug-coated balloon, intravascular Lithotripsy, directional atherectomy, laser debulking devices and stent-grafts offer another chance and better prognosis. The data of these new devices, however, are mainly from low-quality evidence. Therefore, we start this prospective, multicenter, real-world, observational study, providing new data on the safety, efficacy and health economics evaluation of endovascular treatments for Tosaka III in-stent restenosis.

Keywords
in-stent restenosis
Medical subject headings
Peripheral Arterial Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from clinically-driven TLR

    CD-TLR was defined as any reintervention within the target lesion(s) because of recurrent symptoms. Freedom form CD-TLR were defined as the rates of the number of patients who did not receive reintervention verse the number of patients during the follow-up period.

    Measured: 24 months

Secondary outcomes (6)

  1. Primary patency

    The primary patency rate was defined as the percentage of stent patency examined by DUS or CTA examination of lower limb arteries during follow-up.

    Measured: 1month, 6 months,12 months, 18 months ,24 months

  2. Technical success rate

    Successfully revascularize the target vessel. The residual stenosis is <30% and there is no acute thrombosis occurred in the target vessel within 30 days post-operation. The Technical success rate was defined as the rate of the number of patients who receive the treatment as intended verse the number of the patients enrolled.

    Measured: 30 days

  3. Incidence of major adverse events.

    Major adverse events include anyone of the following: all-cause mortality, Myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology, and arterial thrombosis related to endovascular manipulation.

    Measured: 1month, 3 months,6 months, 12 months ,24 months

  4. Freedom from TLR

    TLR was defined as a reintervention performed for >50% diameter stenosis or in the target lesion after documentation of recurrent clinical symptoms following the index procedure or bailout stenting during the index procedure. Freedom form TLR were defined as the rates of the number of patients who did not receive reintervention verse the number of patients during the follow-up period.

    Measured: 1month, 6 months,12 months, 18 months

  5. Vascular quality of life questionnaire(VascuQol)

    The VascuQol was designed as a questionnaire containing five domains: pain (4 items), symptoms (4 items), activities (8 items), social (2 items), and emotional (7 items) to evaluate Health related quality of life (HRQL). Every item has seven response options, with scores ranging from 1 to 7. A total score is the sum of all 25 item scores divided by 25.And both the total score as well as the domain scores range from 1 (worst HRQL) to 7 (best HRQL).The lower the value, the poorer the quality of life.

    Measured: 3 months,6 months, 12 months ,24 months

  6. Health economics evaluation

    All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed.

    Measured: 24months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2021
  2. Study start1 Apr 2021
  3. Primary completion1 Jun 2025
  4. Study completion1 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
322 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04801004
Sponsor's protocol ID
The FP-artery Restore study
Acronym
FP-Restore
Status last verified
Mar 2026
First submitted
10 Mar 2021
Last updated
25 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li X, Zhou M, Ding Y, Wang Y, Cai L, Shi Z. A systematic review and meta-analysis of the efficacy of debulking devices for in-stent restenosis of the femoropopliteal artery. J Vasc Surg. 2020 Jul;72(1):356-366.e5. doi: 10.1016/j.jvs.2019.11.058. Epub 2020 Feb 21.

    PubMed 32093910

  • Tepe G, Schroeder H, Albrecht T, Reimer P, Diehm N, Baeriswyl JL, Brechtel K, Speck U, Zeller T. Paclitaxel-Coated Balloon vs Uncoated Balloon Angioplasty for Treatment of In-Stent Restenosis in the Superficial Femoral and Popliteal Arteries: The COPA CABANA Trial. J Endovasc Ther. 2020 Apr;27(2):276-286. doi: 10.1177/1526602820907917. Epub 2020 Feb 25.

    PubMed 32096451

  • Tosaka A, Soga Y, Iida O, Ishihara T, Hirano K, Suzuki K, Yokoi H, Nanto S, Nobuyoshi M. Classification and clinical impact of restenosis after femoropopliteal stenting. J Am Coll Cardiol. 2012 Jan 3;59(1):16-23. doi: 10.1016/j.jacc.2011.09.036.

    PubMed 22192663

  • Armstrong EJ, Thiruvoipati T, Tanganyika K, Singh GD, Laird JR. Laser Atherectomy for Treatment of Femoropopliteal In-Stent Restenosis. J Endovasc Ther. 2015 Aug;22(4):506-13. doi: 10.1177/1526602815592133. Epub 2015 Jun 30.

    PubMed 26130385

  • Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, Mena-Hurtado C, Beasley R, Soukas P, Colon-Hernandez PJ, Stark MA, Walker C; EXCITE ISR Investigators. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):92-101. doi: 10.1016/j.jcin.2014.09.009. Epub 2014 Dec 10.

    PubMed 25499305

  • Kokkinidis DG, Behan S, Jawaid O, Hossain P, Giannopoulos S, Singh GD, Laird JR, Valle JA, Waldo SW, Armstrong EJ. Laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis: 2-Year outcomes. Catheter Cardiovasc Interv. 2020 Feb 15;95(3):439-446. doi: 10.1002/ccd.28636. Epub 2019 Dec 9.

    PubMed 31816169

  • Kinstner CM, Lammer J, Willfort-Ehringer A, Matzek W, Gschwandtner M, Javor D, Funovics M, Schoder M, Koppensteiner R, Loewe C, Ristl R, Wolf F. Paclitaxel-Eluting Balloon Versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery: 1-Year Results of the PACUBA Trial. JACC Cardiovasc Interv. 2016 Jul 11;9(13):1386-92. doi: 10.1016/j.jcin.2016.04.012.

    PubMed 27388828

  • Bosiers M, Deloose K, Callaert J, Verbist J, Hendriks J, Lauwers P, Schroe H, Lansink W, Scheinert D, Schmidt A, Zeller T, Beschorner U, Noory E, Torsello G, Austermann M, Wauters J. Stent-grafts are the best way to treat complex in-stent restenosis lesions in the superficial femoral artery: 24-month results from a multicenter randomized trial. J Cardiovasc Surg (Torino). 2020 Oct;61(5):617-625. doi: 10.23736/S0021-9509.20.11382-X.

    PubMed 33231029

  • Shammas NW, Petruzzi N, Henao S, Armstrong EJ, Shimshak T, Banerjee S, Latif F, Eaves B, Brothers T, Golzar J, Shammas GA, Jones-Miller S, Christensen L, Shammas WJ. JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study. J Endovasc Ther. 2021 Feb;28(1):107-116. doi: 10.1177/1526602820951916. Epub 2020 Sep 4.

    PubMed 32885736

  • Torsello G, Stavroulakis K, Brodmann M, Micari A, Tepe G, Veroux P, Benko A, Choi D, Vermassen FEG, Jaff MR, Guo J, Dobranszki R, Zeller T; IN.PACT Global Investigators. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort. J Endovasc Ther. 2020 Oct;27(5):693-705. doi: 10.1177/1526602820931477. Epub 2020 Jun 25.

    PubMed 32583749

  • Li X, Zhou M, Ding Y, Wu Z, Feng Z, Guo L, Li Q, Fang X, Sang H, Ye M, Shi Z. Design of the FP-RESTORE study: a protocol for prospective, observational study of real-world treatments with endovascular therapy in patients with femoropopliteal artery Tosaka III in-stent restenosis. BMJ Open. 2022 Dec 6;12(12):e060200. doi: 10.1136/bmjopen-2021-060200.

    PubMed 36600357

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from clinically-driven TLR (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04801004, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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