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.

NCT04801004 | Completed

• 1 other identifier: The FP-artery Restore study
• Study Type: observational
• Target: 322
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Peripheral Arterial Disease

Keywords

in-stent restenosis

Outcome Measures

Primary Outcomes (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.

  24 months

Secondary Outcomes (6)

• Primary patency

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

• Technical success rate

  30 days

• Incidence of major adverse events.

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

• Freedom from TLR

  1month, 6 months,12 months, 18 months

• Vascular quality of life questionnaire(VascuQol)

  3 months,6 months, 12 months ,24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• RenJi Hospital: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• Chengdu University of Traditional Chinese Medicine: collaborator
• Xuanwu Hospital, Beijing: collaborator
• First People's Hospital of Hangzhou: collaborator
• Qingdao Hiser Medical Group: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• Liyuan Hospital of Tongji Medical College of Huazhong University of Science and Technology: collaborator

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, China

Location

Related Publications (11)

• 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.

  PMID: 32093910 BACKGROUND

• 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.

  PMID: 32096451 BACKGROUND

• 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.

  PMID: 22192663 RESULT

• 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.

  PMID: 26130385 RESULT

• 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.

  PMID: 25499305 RESULT

• 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.

  PMID: 31816169 RESULT

• 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.

  PMID: 27388828 RESULT

• 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.

  PMID: 33231029 RESULT

• 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.

  PMID: 32885736 RESULT

• 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.

  PMID: 32583749 RESULT

• 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.

  PMID: 36600357 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 16, 2021
• Study Start: April 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)