TRANSLUMINAL TREATMENT OF ARTERIOSCLEROTIC OBSTRUCTION. DESCRIPTION OF A NEW TECHNIC AND A PRELIMINARY REPORT OF ITS APPLICATION.
C T DOTTER, M P JUDKINS
https://pubmed.ncbi.nlm.nih.gov/14226164Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05780359
Evaluating the Safety and Efficacy of the G-stream Drug-Eluting Peripheral Arterial Stent System in Treating Above-the-Knee Femoropopliteal Artery Stenosis or Occlusion
Led by Shenzhen Salubris Pharmaceuticals Co., Ltd. · Updated on 2023-03-22
280
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
Sponsors
S
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Lead Sponsor
C
Changhai Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the G-stream drug-eluting peripheral arterial stent system in treating narrowing or blockages in the femoropopliteal artery, which includes the superficial femoral artery and proximal popliteal artery. This multicenter, randomized, controlled trial compares the stent system to a drug-eluting balloon catheter called AcoArt-Orchid. The study focuses on patients with peripheral artery disease, aiming to improve blood flow and reduce artery re-narrowing. Participants are randomly assigned to receive either the G-stream drug-eluting stent or the AcoArt-Orchid drug-coated balloon. The stent releases sirolimus to help prevent artery narrowing, and is available in various sizes to fit affected arteries. The balloon catheter uses a special coating to deliver paclitaxel to the vessel wall to enhance treatment. Both devices are designed for use in the superficial femoral and proximal popliteal arteries. The study compares the two devices to see which is more effective and safe. During the study, participants will be monitored for up to 12 months with regular follow-up visits to assess artery openness, device success, clinical outcomes, and any adverse events. Measurements include the percentage of participants maintaining artery openness at 12 months, rates of repeated procedures on the treated vessel, and complications such as thrombosis or amputations. Researchers will use imaging and clinical evaluations to track progress and safety over time. Participants must attend all required visits and comply with study procedures throughout the follow-up period.
CONDITIONS
Brief Title
Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age from 18 to 80 years, male or female
- Diagnosis of lower extremity peripheral artery disease (PAD)
- Rutherford classification between 2 and 5
- Understands the study purpose and voluntarily agrees to participate
- Willing and able to comply with all study requirements and attend all follow-up visits
- Single or tandem lesions in the superficial femoral artery and/or proximal popliteal artery with stenosis 60; 70% but less than 100% and lesion length 20 to 250 mm, or occlusive lesions with length up to 150 mm
- Vessel diameter between 3.5 and 7.5 mm by angiographic assessment
- Successful re-entry device crossing of target lesion
- Residual stenosis after predilation 60; 50% without severe dissection
- Patent ipsilateral iliac inflow with stenosis less than or equal to 50%, or successfully treated lesions with residual stenosis less than 30%
- Patent infrapopliteal and popliteal artery with at least one vessel patent to the ankle or foot before procedure or planned intervention
You will not qualify if you...
- Presence of vasculitis or Berger disease
- Severe coagulation disorders or uncontrolled severe infections
- Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, paclitaxel, rapamycin, contrast dye, or others
- History of distal amputation above the metatarsal in target or contralateral limb
- Severe renal insufficiency with creatinine above 221 umol/L
- Local or systemic thrombolysis within 48 hours prior to procedure
- Acute myocardial infarction within 30 days prior to procedure
- Major surgery within 30 days prior to procedure
- Alimentary tract hemorrhage within 3 months prior to procedure
- Stroke or cerebrovascular accident within 6 months prior to procedure
- Life expectancy less than 12 months
- Previous 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 procedure
- Pregnant, breastfeeding, or planning to become pregnant
- Current participation in another investigational drug or device study
- Other conditions deemed unsuitable by investigator judgment
- Heavily calcified lesions
- Presence of aneurysm in target vessel
- Acute or subacute thrombosis of target vessel
- History of graft intervention in target limb
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Procedure day
Participants receive either the G-stream drug-eluting stent or the drug coating balloon to treat the superficial femoral artery and/or proximal popliteal artery.
1 procedure visit (in-person)
Long-term Monitoring
Duration - 12 months
Participants are monitored for safety and efficacy outcomes including vessel patency, adverse events, and clinical success over 12 months following the procedure.
Follow-up visits at 30 days, 3 months, 6 months, and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
[Percutaneous recanalization after chronic arterial occlusion with a new dilator-catheter (modification of the Dotter technique) (author's transl)].
A Grüntzig, H Hopff
https://pubmed.ncbi.nlm.nih.gov/4434847Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results.
Michael D Dake, Gary M Ansel, Michael R Jaff...
https://pubmed.ncbi.nlm.nih.gov/21953370Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial.
Michael D Dake, Gary M Ansel, Michael R Jaff...
https://pubmed.ncbi.nlm.nih.gov/26969758Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease.
Stefan Müller-Hülsbeck, Koen Keirse, Thomas Zeller...
https://pubmed.ncbi.nlm.nih.gov/27193308Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-up.
Stefan Müller-Hülsbeck, Koen Keirse, Thomas Zeller...
https://pubmed.ncbi.nlm.nih.gov/28948322Risk 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.
Konstantinos Katsanos, Stavros Spiliopoulos, Panagiotis Kitrou...
https://pubmed.ncbi.nlm.nih.gov/30561254