Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery

Official title

A Multicenter, Randomized, Controlled, Superiority Clinical Trial to Evaluate the Safety and Efficacy of Drug-eluting Peripheral Arterial Stent System（G-stream） in the Treatment of the Above-the-knee Femoropopliteal Artery Stenosis or Occlusion

Overview

A multicenter, randomized, controlled, superiority clinical trial to evaluate the efficacy and safety of drug-eluting peripheral arterial stent system（G-stream） in the treatment of femoropopliteal artery stenosis or occlusion.

Detailed description

To evaluate the efficacy and safety of the drug-eluting peripheral arterial stent system（G-stream) in the treatment of superficial femoral artery and/or proximal popliteal artery. Taking the drug eluting balloon catheter (AcoArt-Orchid) as control.

Interventions

• Device Drug eluting stent
  Sirolimus drug-eluting self-expanding stent available from 20mm to 250mm in length, 3.5mm to 7.5mm in diameter of superficial femoral and proximal popliteal arteries (SFA/PPA) cases for inhibiting in-stent restenosis and improve long-term outcome.
• Device drug coating balloon
  A proprietary lipophilic coating technology that uses magnesium sterate as excipient, facilitates paclitaxel transfer to the vessel wall, enhances drug delivery, and brings minimal downstream effect. Available from 20mm to 300 mm in length, 3mm to 12 mm in diameter, fits every SFA cases, reduces radiation exposure time.

Primary outcome measures

• Percentage of Participants Reaching Primary patency [Time frame: 12 months]

Secondary outcome measures (11)

• Device success rate [Time frame: During the procedure]
• Procedural success rate [Time frame: During the procedure]
• Clinical success rate [Time frame: 12 months]
• Percentage of Participants With TLR and clinical drived-TLR (CD-TLR) [Time frame: 30 days, 3 months, 6 months and 12 months]
• Percentage of Participants With Target Vessel Revascularization (TVR) and Clinical Drived-TVR (CD-TVR) [Time frame: 30 days, 3 months, 6 months and 12 months]
• Percentage of Participants With Major Adverse Events (MAEs) [Time frame: 30 days, 3 months, 6 months and 12 months]
• Percentage of Participants With all-cause Death [Time frame: 30 days, 3 months, 6 months and 12 months]
• Distribution of Rutherford classification [Time frame: 30 days, 3 months, 6 months and 12 months]
• Distribution of Ankle Brachial Index(ABI) [Time frame: 6 months and 12 months]
• Percentage of Participants With Lower Extremity Arterial Thrombosis [Time frame: 30 days, 3 months, 6 months and 12 months]
• Percentage of Participants with major and minor amputations of the treated leg [Time frame: 30 days, 3 months, 6 months and 12 months]

Eligibility criteria

Inclusion criteria

• General Inclusion Criteria：

• Age from 18 to 80 years, male or female;
• Patients with Lower extremity peripheral artery disease (PAD);
• With Rutherford classification between 2 and 5;
• Patients understand the purpose of the study, voluntary participation of the study, signs the consent form, willing and able to comply with all requirements, and agrees to attend all required follow-up visits;
• Angiographic Inclusion Criteria： 5.Single lesions or tandem lesions located in the SFA and/or PPA:

• Degree of stenosis ≥ 70% and <100%, Total lesion length ≥ 20 mm and ≤ 250 mm; or
• Occlusive lesions, total lesion length ≤ 150 mm; or
• Series of lesions, total lesion length ≤ 250 mm and length of occlusive lesions ≤ 150 mm; 6.Vessel diameter ≥ 3.5 and ≤ 7.5 mm by visual angiographic assessment; 7.Re-entry device reach and cross a target lesion successfully; 8.Residual stenosis after predilation ≤ 50% without dissection characterized as type D or greater； 9. Patent homolateral iliac inflow (stenosis ≤ 50% ) or homolateral iliac inflow lesion received successfully treated i.e., residual stenosis < 30% after treatment, without severe flow-limiting dissection characterized as type D or greater, without thrombosis, embolism or other serious adverse events; 10.Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (stenosis ≤ 50%) to the ankle or foot before procedure or with planned intervention.

Exclusion criteria

-General Exclusion Criteria：

• Wtih vasculitis or Berger disease;
• With severe coagulation disorders or uncontrolled severe infections, not suitable for intervention procedure;
• Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, paclitaxel, rapamycin, contrast dye or others;
• History of distal amputation (above the metatarsal) in the target limb or contralateral limb;
• Severe renal insufficiency (creatinine > 221 umol/L);
• History of local thrombolysis or systemic thrombolysis within 48 hours prior to procedure;
• History of acute myocardial infarction within 30 days prior to procedure;
• History of major surgery（i.e., open cardiac operation, open abdominal surgery or open operation for peripheral artery disease) within 30 days prior to procedure;
• History of alimentary tract hemorrhage within 3 months prior to procedure;
• History of stroke/cerebrovascular accident (CVA) within 6 months prior to procedure;
• Life expectancy <12 months;
• History of stent, drug-coated balloon or bypass surgery in the target lesion;
• Use of atherectomy, laser, cryoplasty or other debulking devices in the target lesion during the index procedure;
• Pregnant, breast feeding, or plan to become pregnant;
• Current participation in another investigational drug or device clinical study;
• According to the judgement of the investigator, other situations that are not suitable for enrollment;

• Angiographic Exclusion Criteria:
• Heavily calcified lesions;
• Presence of aneurysm in the target vessel;
• Acute or subacute thrombosis of the target vessel;
• History of graft intervention in the target limb.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Changhai Hospital of Shanghai — Shanghai

Publications

• DOTTER CT, JUDKINS MP. TRANSLUMINAL TREATMENT OF ARTERIOSCLEROTIC OBSTRUCTION. DESCRIPTION OF A NEW TECHNIC AND A PRELIMINARY REPORT OF ITS APPLICATION. Circulation. 1964 Nov;30:654-70. doi: 10.1161/01.cir.30.5.654. No abstract available. PMID 14226164
• Gruntzig A, Hopff H. [Percutaneous recanalization after chronic arterial occlusion with a new dilator-catheter (modification of the Dotter technique) (author's transl)]. Dtsch Med Wochenschr. 1974 Dec 6;99(49):2502-10, 2511. doi: 10.1055/s-0028-1108161. No abstract available. German. PMID 4434847
• Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011 Oct 1;4(5):495-504. doi: 10.1161/CIRC PMID 21953370
• Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Machan LS, Snyder SA, O'Leary EE, Ragheb AO, Zeller T; Zilver PTX Investigators. Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial. Circulation. 2016 Apr 12;133(15):1472-83; discussion 1483. doi: 10.1161/CIRCULATIONAHA.115.016900. Epub 2016 Mar 11. PMID 26969758
• Muller-Hulsbeck S, Keirse K, Zeller T, Schroe H, Diaz-Cartelle J. Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther. 2016 Oct;23(5):701-7. doi: 10.1177/1526602816650206. Epub 2016 May 18. PMID 27193308
• Muller-Hulsbeck S, Keirse K, Zeller T, Schroe H, Diaz-Cartelle J. Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-up. Cardiovasc Intervent Radiol. 2017 Dec;40(12):1832-1838. doi: 10.1007/s00270-017-1771-5. Epub 2017 Sep 25. PMID 28948322
• Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2018 Dec 18;7(24):e011245. doi: 10.1161/JAHA.118.011245. PMID 30561254

Identifiers

NCT: NCT05780359 · TP-GS009

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗