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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Drug eluting stent; Device: drug coating balloon

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.

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Changhai Hospital of Shanghai
      • Contact: Junmin Bao; Phone Number: 021-31166666; Email: baojm@189.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• General Inclusion Criteria：

  1. Age from 18 to 80 years, male or female;
  2. Patients with Lower extremity peripheral artery disease (PAD);
  3. With Rutherford classification between 2 and 5;
  4. 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:

  1. Degree of stenosis ≥ 70% and <100%, Total lesion length ≥ 20 mm and ≤ 250 mm; or
  2. Occlusive lesions, total lesion length ≤ 150 mm; or
  3. 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：

1. Wtih vasculitis or Berger disease;
2. With severe coagulation disorders or uncontrolled severe infections, not suitable for intervention procedure;
3. Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, paclitaxel, rapamycin, contrast dye or others;
4. History of distal amputation (above the metatarsal) in the target limb or contralateral limb;
5. Severe renal insufficiency (creatinine > 221 umol/L);
6. History of local thrombolysis or systemic thrombolysis within 48 hours prior to procedure;
7. History of acute myocardial infarction within 30 days prior to procedure;
8. 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;
9. History of alimentary tract hemorrhage within 3 months prior to procedure;
10. History of stroke/cerebrovascular accident (CVA) within 6 months prior to procedure;
11. Life expectancy <12 months;
12. History of stent, drug-coated balloon or bypass surgery in the target lesion;
13. Use of atherectomy, laser, cryoplasty or other debulking devices in the target lesion during the index procedure;
14. Pregnant, breast feeding, or plan to become pregnant;
15. Current participation in another investigational drug or device clinical study;

16. According to the judgement of the investigator, other situations that are not suitable for enrollment;

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug eluting stent; Device: Drug-eluting peripheral arterial（G-stream） stent system Manufacturer：Alain Medical (Beijing) Co., Ltd.	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.
Active Comparator: Drug coating balloon; Device: AcoArt-Orchid® Drug Eluting Balloon Catheter Manufacturer: Acotec Scientific Co., Ltd	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.; Other Names: drug eluting percutaneous transluminal angioplasty (PTA) balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success rate	Device success was defined as successful arrival of stent/balloon to the lesion. And subsequent release of the stent delivery system or dilation of balloon. Then withdraw delivery system successfully.	During the procedure
Procedural success rate	Procedural success was defined as delivery and deployment of the assigned stent/balloon to the target lesion to achieve residual angiographic stenosis no greater than 50% for balloon and 30% for stent.	During the procedure
Clinical success rate	Clinical success was defined as procedural success without server complications (death, target limb major amputation and/or target lesion revascularization (TLR).	12 months
Percentage of Participants With TLR and clinical drived-TLR (CD-TLR)	TLR is defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure.	30 days, 3 months, 6 months and 12 months
Percentage of Participants With Target Vessel Revascularization (TVR) and Clinical Drived-TVR (CD-TVR)	TVR is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure.	30 days, 3 months, 6 months and 12 months
Percentage of Participants With Major Adverse Events (MAEs)	MAEs defined as all-cause death, target limb major amputation and/or target lesion revascularization (TLR).	30 days, 3 months, 6 months and 12 months
Percentage of Participants With all-cause Death		30 days, 3 months, 6 months and 12 months
Distribution of Rutherford classification	Changing in categories of Rutherford classification.	30 days, 3 months, 6 months and 12 months
Distribution of Ankle Brachial Index(ABI)	Changing in ABI between 6 to 12 months.	6 months and 12 months
Percentage of Participants With Lower Extremity Arterial Thrombosis		30 days, 3 months, 6 months and 12 months
Percentage of Participants with major and minor amputations of the treated leg	Major amputation defined as amputation above the ankle and minor as below the ankle.	30 days, 3 months, 6 months and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AE) and Serious Adverse Events (SAE) related to Device	Percentage of Participants with AE and SAE related to device.	24 months
other Adverse Events (AE) and Serious Adverse Events (SAE)	Percentage of Participants with AE and SAE not related to device.	24 months
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%).	24 months
Percentage of Participants With TLR and CD-TLR	TLR is defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure.	18 months and 24 months
Percentage of Participants With TVR and CD-TVR	TVR is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure.	18 months and 24 months
Percentage of Participants With MAEs	MAEs defined as all-cause death, target limb major amputation and/or target lesion revascularization (TLR).	18 months and 24 months
Percentage of Participants With all-cause Death		18 months and 24 months
Distribution of Rutherford classification	Changing in categories of Rutherford classification.	18 months and 24 months
Distribution of Ankle Brachial Index(ABI)	Changing in ABI during 24 months.	24 months
Percentage of Participants With Lower Extremity Arterial Thrombosis		18 months and 24 months
Percentage of Participants with major and minor amputations of the treated leg	Major amputation defined as amputation above the ankle and minor as below the ankle.	18 months and 24 months

Collaborators and Investigators

• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
• Collaborators: Changhai Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Circulation. 2019 Feb 19;139(8):e42.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2022
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): August 31, 2026

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Peripheral Artery Disease; drug eluting stent; drug coating ballon
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: TP-GS009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No