View clinical trials related to Peripheral Vascular Diseases.
Filter by:The BELTHROM trial investigates the efficacy and safety of the ClearLumen II Peripheral Thrombectomy System recanalization of acute and subacute thrombotic femoropopliteal occlusions (Acute Limb Ischemia (ALI); Rutherford I, IIa, IIb and III). An expected total of 50 patients will be treated. The lesion is located within the femoropopliteal artery (native, in-stent or bypass graft). During the procedure, the device is introduced, activated and slowly advanced into the occlusion to clean out the wall-adherent thrombotic material. If residual underlying stenosis of >30% persists additional endovascular treatment can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1 month post-procedure. The primary efficacy endpoint is the technical success of the ClearLumen II Peripheral Thrombectomy System, defined as removal of ≥90% acute clot as documented by angiography. The primary safety endpoint is defined as the absence of device-related complications, which is defined as embolization, perforation or dissection caused by the ClearLumen II Peripheral Thrombectomy System. Secondary endpoints include procedural success, percent clot removed by the ClearLumen II Peripheral Thrombectomy System, clinical success at 1 month follow-up visit, 30-day target lesion revascularization, 30-days serious adverse events and 30-days adverse events.
This trial is a First in Human early feasibility study of a novel atherectomy device to treat peripheral artery disease. The trial is a prospective, single arm design that will enroll 10 patients at 1 - 2 sites. Patients will be followed at 30 days and 6 months to evaluate vessel patency following treatment. Safety will be assessed by monitoring adverse events throughout the study. Safety and Efficacy will be evaluated by comparing study results to established performance criteria,
The GIFT pilot study will investigate the optimal subcutaneous dose and safety of subcutaneously administered unacylated ghrelin in older people with peripheral artery disease (PAD).
Prospective interventional study. The aim is to analyze the effect of usual ongoing treatments over microvascular cutaneous response to galvanic current applications (CIV: current induced vasodilatation) with tissue vitality (TiVi) system on the forearm of subjects referred for ultrasound investigations due to suspicion of peripheral disease. Hypothesis is that the use of aspirin (even at low dose) abolishes the response. This test could make it possible to detect the functional effects of low dose aspirin without using biological tests. A routine clinical application could be to use this CIV to verify adherence to aspirin.
The BELSTREAM Trial investigates the efficacy of the LifeStream Peripheral Stent Graft System in the treatment of iliac stenotic or occlusive lesions (TASC C and D). An expected total of 70 patients will be treated. The lesion is located within the native Iliac arteries. Prior to stenting with the LifeStream Peripheral Stent Graft System, pre-dilatation can be performed according to the physician's discretion. Also post-dilatation can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1, 6, 12, 24 ,36 ,48 and 60-month post-procedure. .The primary efficacy endpoint of the study is the primary patency at 12 months. The primary safety endpoint is the freedom of periprocedural Serious Adverse Events (SAEs). Secondary endpoint include primary patency rate at 1 ,6 ,24 ,36 ,48 and 60 month, stent graft occlusion rate at pre-discharge, 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, anke-brachial index (ABI) at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, amputation rate at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, technical success and clinical success at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up.
The T.I.N.T.I.N. study investigates the safety and efficacy of the combination therapy with the Luminor drug coated balloon (DCB) and the iVolution stent in the treatment of TASC C and D femoropopliteal lesions. An expected total of 100 patients will be treated in the scope of this study. The lesion is located within the native superficial femoral artery and/or the popliteal artery. Prior to dilatation with the Luminor DCB, pre-dilatation with the Oceanus balloon is mandatory. After dilatation with the Luminor DCB, stenting with the iVolution stent need to be performed. Post-dilatation can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1, 6, 12, 24, 36, 48 and 60 month post-procedure. The primary efficacy endpoint of the study is defined as the freedom from clinically-driven target lesion revascularization (TLR) at 12 months. Secondary endpoints include primary patency rate at 6 and 12 months, freedom from clinically-driven TLR at 6, 24, 36, 48 and 60 months, clinical success at 1, 6, 12, 24, 36, 48 and 60 months and freedom from serious adverse events at pre-discharge, 1, 6, 12, 24, 36, 48 and 60 months follow-up.
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.
The purpose of this trial is to evaluate the safety and efficacy of sonodynamic therapy (SDT) in reducing atherosclerotic plaques inflammation and increasing peak walking time (PWT) among peripheral artery disease (PAD) patients with symptom of intermittent claudication.
Rinexin® Tab (Cilostazol 100mg, Ginkgo biloba leaf extract 80mg) has been widely used as an anti-platelet agent for the treatment of PAD. SID142 is a new controlled-release product improved patient's convenience and disadvantage of dosage regimen of previous drug. The aim of this study was to compare the efficacy and safety of SID142 and Rinexin® Tab in patients with PAD
A retrospective study to evaluate Turbo Power laser atherectomy + drug coated balloon (DCB) angioplasty for the treatment of femoropopliteal de novo/restenotic lesions and in-stent restenosis (ISR).