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

Primary Purpose

Peripheral Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug eluting stent
drug coating balloon
Sponsored by
Shenzhen Salubris Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring drug eluting stent, drug coating ballon, Peripheral Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Changhai Hospital of ShanghaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug eluting stent

Drug coating balloon

Arm Description

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

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

Outcomes

Primary Outcome Measures

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%);

Secondary Outcome Measures

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.
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.
Clinical success rate
Clinical success was defined as procedural success without server complications (death, target limb major amputation and/or target lesion revascularization (TLR).
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.
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.
Percentage of Participants With Major Adverse Events (MAEs)
MAEs defined as all-cause death, target limb major amputation and/or target lesion revascularization (TLR).
Percentage of Participants With all-cause Death
Distribution of Rutherford classification
Changing in categories of Rutherford classification.
Distribution of Ankle Brachial Index(ABI)
Changing in ABI between 6 to 12 months.
Percentage of Participants With Lower Extremity Arterial Thrombosis
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.

Full Information

First Posted
March 8, 2023
Last Updated
March 20, 2023
Sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Collaborators
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05780359
Brief Title
Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
Acronym
G-streamPAD
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Collaborators
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
drug eluting stent, drug coating ballon, Peripheral Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug eluting stent
Arm Type
Experimental
Arm Description
Device: Drug-eluting peripheral arterial(G-stream) stent system Manufacturer:Alain Medical (Beijing) Co., Ltd.
Arm Title
Drug coating balloon
Arm Type
Active Comparator
Arm Description
Device: AcoArt-Orchid® Drug Eluting Balloon Catheter Manufacturer: Acotec Scientific Co., Ltd
Intervention Type
Device
Intervention Name(s)
Drug eluting stent
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
drug coating balloon
Other Intervention Name(s)
drug eluting percutaneous transluminal angioplasty (PTA) balloon
Intervention Description
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 Measure Information:
Title
Percentage of Participants Reaching Primary patency
Description
Primary patency defined as freedom from clinically-driven target lesion revascularization and CT angiography diagnosis of freedom from restenosis (ie, stenosis ≤ 50%);
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Device success rate
Description
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.
Time Frame
During the procedure
Title
Procedural success rate
Description
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.
Time Frame
During the procedure
Title
Clinical success rate
Description
Clinical success was defined as procedural success without server complications (death, target limb major amputation and/or target lesion revascularization (TLR).
Time Frame
12 months
Title
Percentage of Participants With TLR and clinical drived-TLR (CD-TLR)
Description
TLR is defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure.
Time Frame
30 days, 3 months, 6 months and 12 months
Title
Percentage of Participants With Target Vessel Revascularization (TVR) and Clinical Drived-TVR (CD-TVR)
Description
TVR is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure.
Time Frame
30 days, 3 months, 6 months and 12 months
Title
Percentage of Participants With Major Adverse Events (MAEs)
Description
MAEs defined as all-cause death, target limb major amputation and/or target lesion revascularization (TLR).
Time Frame
30 days, 3 months, 6 months and 12 months
Title
Percentage of Participants With all-cause Death
Time Frame
30 days, 3 months, 6 months and 12 months
Title
Distribution of Rutherford classification
Description
Changing in categories of Rutherford classification.
Time Frame
30 days, 3 months, 6 months and 12 months
Title
Distribution of Ankle Brachial Index(ABI)
Description
Changing in ABI between 6 to 12 months.
Time Frame
6 months and 12 months
Title
Percentage of Participants With Lower Extremity Arterial Thrombosis
Time Frame
30 days, 3 months, 6 months and 12 months
Title
Percentage of Participants with major and minor amputations of the treated leg
Description
Major amputation defined as amputation above the ankle and minor as below the ankle.
Time Frame
30 days, 3 months, 6 months and 12 months
Other Pre-specified Outcome Measures:
Title
Adverse Events (AE) and Serious Adverse Events (SAE) related to Device
Description
Percentage of Participants with AE and SAE related to device.
Time Frame
24 months
Title
other Adverse Events (AE) and Serious Adverse Events (SAE)
Description
Percentage of Participants with AE and SAE not related to device.
Time Frame
24 months
Title
Percentage of Participants Reaching Primary patency
Description
Primary patency defined as freedom from clinically-driven target lesion revascularization and CT angiography diagnosis of freedom from restenosis (ie, stenosis ≤ 50%).
Time Frame
24 months
Title
Percentage of Participants With TLR and CD-TLR
Description
TLR is defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure.
Time Frame
18 months and 24 months
Title
Percentage of Participants With TVR and CD-TVR
Description
TVR is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure.
Time Frame
18 months and 24 months
Title
Percentage of Participants With MAEs
Description
MAEs defined as all-cause death, target limb major amputation and/or target lesion revascularization (TLR).
Time Frame
18 months and 24 months
Title
Percentage of Participants With all-cause Death
Time Frame
18 months and 24 months
Title
Distribution of Rutherford classification
Description
Changing in categories of Rutherford classification.
Time Frame
18 months and 24 months
Title
Distribution of Ankle Brachial Index(ABI)
Description
Changing in ABI during 24 months.
Time Frame
24 months
Title
Percentage of Participants With Lower Extremity Arterial Thrombosis
Time Frame
18 months and 24 months
Title
Percentage of Participants with major and minor amputations of the treated leg
Description
Major amputation defined as amputation above the ankle and minor as below the ankle.
Time Frame
18 months and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junmin Bao
Phone
021-31166666
Email
baojm@189.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14226164
Citation
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.
Results Reference
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PubMed Identifier
4434847
Citation
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.
Results Reference
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PubMed Identifier
21953370
Citation
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.
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PubMed Identifier
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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.
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Citation
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.
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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.
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Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery

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