Peripheral Artery Disease
Conditions
Keywords
drug eluting stent, drug coating ballon, Peripheral Artery Disease
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.
Interventions
DEVICEDrug 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.
DEVICEdrug 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.
Sponsors
Changhai Hospital
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reaching Primary patency | 12 months | Primary patency defined as freedom from clinically-driven target lesion revascularization and CT angiography diagnosis of freedom from restenosis (ie, stenosis ≤ 50%); |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device success rate | During the procedure | 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 | During the procedure | 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 | 12 months | 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) | 30 days, 3 months, 6 months and 12 months | 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) | 30 days, 3 months, 6 months and 12 months | 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) | 30 days, 3 months, 6 months and 12 months | MAEs defined as all-cause death, target limb major amputation and/or target lesion revascularization (TLR). |
| Percentage of Participants With all-cause Death | 30 days, 3 months, 6 months and 12 months | — |
| Distribution of Rutherford classification | 30 days, 3 months, 6 months and 12 months | Changing in categories of Rutherford classification. |
| Distribution of Ankle Brachial Index(ABI) | 6 months and 12 months | Changing in ABI between 6 to 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 | 30 days, 3 months, 6 months and 12 months | Major amputation defined as amputation above the ankle and minor as below the ankle. |
Other
| Measure | Time frame | Description |
|---|---|---|
| other Adverse Events (AE) and Serious Adverse Events (SAE) | 24 months | Percentage of Participants with AE and SAE not related to device. |
| Percentage of Participants Reaching Primary patency | 24 months | Primary patency defined as freedom from clinically-driven target lesion revascularization and CT angiography diagnosis of freedom from restenosis (ie, stenosis ≤ 50%). |
| Percentage of Participants With TLR and CD-TLR | 18 months and 24 months | TLR is defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure. |
| Percentage of Participants With TVR and CD-TVR | 18 months and 24 months | TVR is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. |
| Percentage of Participants With MAEs | 18 months and 24 months | MAEs defined as all-cause death, target limb major amputation and/or target lesion revascularization (TLR). |
| Percentage of Participants With all-cause Death | 18 months and 24 months | — |
| Distribution of Rutherford classification | 18 months and 24 months | Changing in categories of Rutherford classification. |
| Distribution of Ankle Brachial Index(ABI) | 24 months | Changing in ABI during 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 | 18 months and 24 months | Major amputation defined as amputation above the ankle and minor as below the ankle. |
| Adverse Events (AE) and Serious Adverse Events (SAE) related to Device | 24 months | Percentage of Participants with AE and SAE related to device. |
Countries
China
Outcome results
None listed