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

NCT05780359 | Recruiting DMC

• 1 other identifier: TP-GS009
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Artery Disease

Keywords

drug eluting stent; drug coating ballon; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Reaching Primary patency

  Primary patency defined as freedom from clinically-driven target lesion revascularization and CT angiography diagnosis of freedom from restenosis (ie, stenosis ≤ 50%);

  12 months

Secondary Outcomes (11)

• Device success rate

  During the procedure

• Procedural success rate

  During the procedure

• Clinical success rate

  12 months

• Percentage of Participants With TLR and clinical drived-TLR (CD-TLR)

  30 days, 3 months, 6 months and 12 months

• Percentage of Participants With Target Vessel Revascularization (TVR) and Clinical Drived-TVR (CD-TVR)

  30 days, 3 months, 6 months and 12 months

Other Outcomes (11)

• Adverse Events (AE) and Serious Adverse Events (SAE) related to Device

  24 months

• other Adverse Events (AE) and Serious Adverse Events (SAE)

  24 months

• Percentage of Participants Reaching Primary patency

  24 months

Study Arms (2)

Drug eluting stent

EXPERIMENTAL

Device: Drug-eluting peripheral arterial（G-stream） stent system Manufacturer：Alain Medical (Beijing) Co., Ltd.

Device: Drug eluting stent

Drug coating balloon

ACTIVE COMPARATOR

Device: AcoArt-Orchid® Drug Eluting Balloon Catheter Manufacturer: Acotec Scientific Co., Ltd

Device: drug coating balloon

Interventions

Drug eluting stent DEVICE

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.

Drug eluting stent

drug coating balloon DEVICE

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.

Also known as: drug eluting percutaneous transluminal angioplasty (PTA) balloon

Drug coating balloon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead
• Changhai Hospital: collaborator

Study Sites (1)

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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/CIRCINTERVENTIONS.111.962324. Epub 2011 Sep 27.

  PMID: 21953370 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 22, 2023
• Study Start: May 27, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)