View clinical trials related to Peripheral Vascular Diseases.
Filter by:According to epidemiological surveys in various countries around the world, the prevalence of erectile dysfunction in men over the age of 40 is about 40%. Previous angiography studies have shown that nearly 70% of erectile dysfunction patients do have pelvic arterial stenosis. Our team leads the world in the use of percutaneous angioplasty combined with drug-eluting stents or paclitaxel-coated balloons to delineate the stenosis of the pelvic pudendal artery and penile artery The successful report of erectile dysfunction shows that the 12-month erectile function improvement rate is nearly 60%, and the vascular restenosis rate is also about 40% to 50%, obviously there is room for improvement. This study aims to observe the clinical efficacy, safety and lower restenosis rate of the newly developed "Selution SLR™ sirolimus drug sustained-release coated balloon" in patients with distal internal pudendal artery and penile artery stenosis complicated with erectile dysfunction . Compared with drug-eluting stents and paclitaxel drug-coated balloons, the Sirolimus drug-coated balloon has two advantages: one is that the clinical performance of sirolimus is much better than that of paclitaxel when used in drug-eluting stents; the other is that there is no indwelling stent in the Therefore, it can reduce the local stimulation of blood vessels and maintain the biological activity of blood vessels. Selution SLR™ sirolimus drug sustained-release coated balloon has obtained European Union approval for marketing, and has also been granted four Breakthrough Device Designation Status by the U.S. Food and Drug Administration (FDA): coronary artery disease, coronary artery disease In-stent restenosis, infra-knee artery disease, and arteriovenous canals.
The objective of this study is to obtain outcomes following dissection repair with the Tack Endovascular System in a broad population of patients undergoing endovascular treatment of lesions within the superficial femoral, popliteal, peroneal, and/or tibial arteries.
This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System).
Sympathetic overactivity partly promotes the development of peripheral artery disease which mainly leads to ischemia of the lower limbs. Endovascular arterial denervation (ED) is a minimally invasive technique which could deliver Radiofrequency energy by a multi-electrode catheter to the Lower limb artery to restore Sympathetic activity. The purpose of this study is to evaluate the effects of multi-electrode radiofrequency ablation system on lower limb ischemia with PAD.
The present post-market surveillance study aims to evaluate the safety and effectiveness of the Angio-SealTM VIP VCD in patients undergoing endovascular procedures via femoral access in real-world setting.
This study is designed to evaluate the efficacy (device deployment characteristics and performance) and safety (adverse access site related events) of Perclose ProGlide (Abbott Vascular Devices) for femoral access site closure in patients undergoing peripheral vascular diagnostic and interventional procedures in comparison with Angio-seal VIP (St. Jude Medical).
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
The BARISTA study tests the safety and efficacy of the Restorer stent from the company iVascular. This stent is a medical device that is already approved for use in Europe, to treat stenotic (narrowed) iliac arteries. 200 Belgian patients from 13 different hospitals will be included in this study. Patients will be medically monitored for 2 years from the day of the study procedure. The treatment of the stenotic iliac arteries will be according to the standard of care, using the Restorer stent. This endovascular treatment consists of introducing the necessary materials in the blood vessels by a puncture in the groin under general or local anaesthesia, after which a thin plastic tube will be inserted into the femoral artery through the puncture site, until the stenotic iliac artery is reached. Medical imaging is done by angiography. The stenotic/occluded section of the artery will first be dilated by inserting and inflating a balloon. Next, the Restorer stent will be placed and, if necessary, another balloon may be inserted and inflated to allow the stent to fit nicely to the vessel wall and optimise the result. As per standard of care, follow-up will be done in the hospital after 1, 6, 12, and 24 months. During these visits, an ultrasound scan of the treated artery will be taken to evaluate the patency of the blood vessel. Also, two short questionnaires will be completed asking about the quality of life and walking difficulties. The use of medication will be recorded. If adverse events are experienced, they will be reported.
The objective of this clinical investigation is to evaluate, in a controlled setting, the 12 months safety and efficacy of the combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device, for PACSS 3 and PACSS 4 calcified femoropopliteal disease.
The rationale of this study is to confirm and support the clinical safety and performance of the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated Balloons, the Angiolite BTK Sirolimus Eluting Peripheral Stent System and the Sergeant Peripheral Support Catheter in a real-word population of 143 patients who underwent an endovascular intervention the popliteal and/or infrapopliteal arteries within standard-of-care (SOC) where at least 1 of the investigational products from iVascular were used.