Active clinical trials for "Peripheral Vascular Diseases"

Patients with peripheral arterial disease often have walking impairment due to insufficient oxygen supply to lower extremity skeletal muscle. In an aging rat model, we have previously shown that daily calf muscle stretching improves endothelium-dependent dilation of soleus muscle arterioles and blood flow during exercise. The effect of muscle stretching on endothelial function and walking distance in patients with peripheral arterial disease is unknown. We performed a prospective, randomized, non-blinded, crossover study in 13 patients with stable symptomatic peripheral artery disease. Patients were randomized to undergo either 4 weeks of passive calf muscle stretching (ankle dorsiflexion splints applied 30 minutes/day, 5 days/week) followed by 4 weeks of no muscle stretching (control group) and vice versa. Endothelium-dependent flow-mediated dilation and endothelium- independent nitroglycerin-induced dilation of the popliteal artery and a 6 minute walk test were evaluated at baseline and after each 4 week treatment interval. Patients crossed over to the other treatment arm after 4 weeks and endothelium-dependent flow-mediated dilation and endothelium- independent nitroglycerin-induced dilation of the popliteal artery and the 6 minute walk test were repeated.

The MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes using a new calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes. The MODIFY Pilot study will evaluate safety and performance measurements.

A prospective, multicenter, randomized study evaluating the use of Jetstream Atherectomy (JS) followed by DCB in comparison to the use of plain old balloon angioplasty (POBA) followed by DCB alone in the treatment of complex lesions in femoropopliteal arteries in subjects with claudication (Rutherford Clinical Category (RCC) of 2-4) (complex lesions are defined as long (≥ 10 cm) lesions, or moderately or highly calcified lesions, or chronic total occlusions irrespective of length).

In 2010, we completed a phase 1 to 2a clinical trial of pCMV-vegf165 in patients with chronic lower limb ischemia (stage 2a to 3 according to Fontaine classification modified by A. V. Pokrovsky) who were not suitable for reconstructive surgery or endovascular treatment. This study demonstrated the safety, feasibility, and short-term(3 months) efficacy of pCMV-vegf165 gene transfer,12,13which lead to conducting a phase 2b to 3 multicenter clinical trial. The study was conducted under the control of the Russian Ministry of Health and was completed in 2011. Patients enrolled in the study were subjected to a 6-month

The main objective is to evaluate the effect of Propionyl-L-Carnitine Hydrochloride on clinical pharmacokinetic characteristics and its effect of clinical pharmacokinetic characteristics and safety on healthy Chinese subjects to provide a basis for market authorization registration

The primary objective for this study is to prove the safety and effectiveness of the Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with catheter to vessel sizing of at least 50%.

Remote ischemic Preconditioning (RIPC) is a phenomena first observed in cardio-thoracic patients in which exposing the limbs for periods of short intermittent ischemia produces protective effect on heart muscle. The concept was applied to many other parts of the body and the results are positive so far. No human trials on this concept has been conducted in patients with peripheral vascular disease so far but applying the concept for healthy individuals shows vessels dilatation and animal trials shows degree of new vessels formation in addition to reports of symptoms improvement. The trial candidates will be allocated blindly in 4 groups. All groups will have advice about exercise which is the standard practice now. The first group will have supervised exercise. The second group will in addition to the supervised exercise get the ischemic preconditioning with the blood pressure cuff. The third group will get the ischemic preconditioning and the fourth group will get the standard exercise advice. All candidates will have Magnetic Resonance Image Scan (MRA) for their blood vessels in the beginning of the trial and again at the end. The effect of the RIPC (Remote ischemic Preconditioning) and exercises on patient symptoms, new vessel formation and other parameters will be recorded

This study will investigate if patients with peripheral artery disease (PAD) can be successfully incorporated into an already existing Cardiac Rehabilitation programme. One group of PAD patients will exercise as a group, and the other group will exercise alongside patients with coronary artery disease (CAD).

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.

The aim of the conducted research is to evaluate the protective effect of rivaroxaban (trade name of the Xarelto medicinal product), administered together with acetylsalicylic acid (ASA), in comparison with the effectiveness of using ASA alone, in relation to the distance of claudication and exercise tolerance in patients with PAD over a period of 3 months. At present, COMPASS results show that rivaroxaban vascular dose (2.5 mg twice daily) in combination with ASA (75-100 mg once daily) provides more effective cardiovascular protection (defined as cardiovascular death, vascular, myocardial infarction and stroke) compared to ASA alone. So far, however, no scientific studies have been carried out into account the effect of the drug on the progress of PAD and exercise tolerance in patients.