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Tests treatment safety and results for Peripheral Artery Disease
Official title Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
ClinicalTrials.gov ID: NCT05780359
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- General ：
- 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...
You likely can't join if
- -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);
See the full eligibility criteria
- General ：
- 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 ： 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...
- -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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.