View clinical trials related to Angioplasty.
Filter by:Peripheral arterial disease (PAD) affects more than 200 million people worldwide. Although over 50% are asymptomatic, it accounts for 4% of all amputations. The ischemic limb must be revascularized to help wound healing, reduce the pain of ischemia and preserve the limb's function. So, surgical and percutaneous revascularization choices must be considered in CLI. Classically, CLI revascularization aims to provide at least one patent vessel that delivers in-line flow to the foot. Today, the investigators live in a new era of angioplasty evolving and substituting open vascular surgery, so expanding research on endovascular strategy has been noticed.This confirms the profound impact of angioplasty in vascular surgery as one of the fastest-growing branches of medicine Infrapopliteal artery occlusive disease (IPOD) is a significant cause of critical limb-threatening ischemia (CLTI). The worldwide prevalence of IPOD is between 4.5% and 29%, and most patients live in low-income countries. The angiosomal concept was derived from plastic surgery for the skin flap. This concept delineates the human body into three-dimensional blocks of tissue from the skin to bone and also provides practical application of vascular anatomy for reconstructive surgery. An angiosome is an anatomic unit of tissue consisting of skin, subcutaneous, muscle, and bone fed by a source artery and drained by a specific vein. According to the angiosomal concept, the foot is divided into six distinct angiosomes fed by source arteries, three from the posterior tibial, two from the peroneal, and one from the anterior tibial artery, with functional artery-to-artery connections among muscle, fascia, and skin. Numerous direct inter-arterial connections occur between the foot's main arteries, which provide alternative pathways of blood flow when disruption or compromise affects the arteries that directly feed the angiosome. On the other hand, in patients with CLI, where only one vessel runoff can be established to the foot, direct flow into a patent pedal arch is essential to improve their clinical outcomes. Conventional Endovascular therapy aims to the re-establishment of pulsatile straight-line flow to the lower limb. This results in relieving ischemic pain, healing ulcers, achieving limb salvage, improving quality of life, and potentially prolonging survival. So it became essential to know the differential impact of both concepts on CLI revascularization.
Calcified lesions are very frequent among coronary artery disease stenotic lesions. The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging. Calcified lesions are very frequent among coronary artery disease stenotic lesions. The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging. The presence of calcifications increases the risk of adverse evolution after PCI , including stent restenosis, thrombosis and need for repeat revascularisation. Specific and appropriate tools can be used for calcified lesions management , including high pressure non compliant balloons, intravascular lithotripsy and rotablator. Intra vascular OCT has a high sensitivity and specificity for calcium detection among coronary artery lesions. Compared to IVUS, OCT allows a better quantification of calcium sheets (depth extension ) . Several intra coronary imaging based calcified lesions management algorithms have been proposed , but none have been validated in clinical practice.
The objective of this prospective, multicenter, non-randomized, single-arm observational study is to evaluate the efficacy and the safety of the iCover covered stent for the treatment of de novo aorto-iliac atherosclerotic lesions in patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5).
Peripheral arterial disease (PAD) caused by atherosclerosis causes damage to the arteries originating in the aorta (descending) from the iliacs to the extremities of the lower limbs. It causes significant morbidity and mortality. Percutaneous revascularization plays a key role in the management of these patients. Many percutaneous treatment options have been developed: arteriectomy, naked stents, active balloons and active stents. Of these, only paclitaxel-active stents were successful in reducing the rates of restenosis and reoperation in patients with superficial femoral artery injury.The main objective is to study symptomatic improvement at 1 year of patients treated with revascularization of the lower limbs.
Coronary calcified lesions will have an increasing impact in the daily practice of coronary angioplasty, considering the epidemiological explosion of factors favoring coronary calcifications, first of all diabetes. Moreover, calcified lesions are underestimated in angiography and associated with an increase in angiographic complications, as well as with a worse clinical prognosis. The usual techniques for the preparation of calcified plaque, in particular rotary atherectomy, have a low penetration rate in France (3% of procedures) and are associated with an increase in per-procedural complications without clinical evidence of effectiveness4. A new device has been developed by Schockwave Medical Inc. for the treatment of calcified lesions to facilitate stent delivery: the C2 Shockwave Medical® Coronary Lithotripsy System (IVL), Inc. This system uses the principle of lithotripsy to induce microfractures in the calcified plaque prior to low-pressure balloon dilatation. The objective of the study is to evaluate the safety and performance of the C2 Shockwave Medical® (IVL), Inc. coronary lithotripsy system in coronary angioplasty in the general population in France.
There have been a number of randomized controlled studies (RCT) showing the efficacy of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions. However, these studies have been carefully designed, and most of them have excluded long-length lesions and severely calcified lesions. In addition to being used alone in the real word, drug-coated balloons (DCB) are also used in combination with stents or debulking devices, but in these randomized controlled studies (RCT) they are only compared with standard percutaneous transluminal angioplasty (PTA). Therefore, the investigators initiated this study, which is a prospective, multicenter, observational real-world study of short and long-term outcome in endovascular treatment of femoropopliteal arterial occlusive lesions with DCB.
The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and/or long lesions/occlusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.
OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter randomized controlled study aims to evaluate the long-term efficacy and safety of paclitaxel coated balloon in the treatment of native large coronary arteries by OCT guided is not inferior to drug-eluting stent.
Endovascular revascularization is an effective procedure in treatment of chronic critical limb ischemia. The less invasive procedure in high risk patients produce the benefit to the patients. However, some of the patients cannot tolerate local anaesthesia. These patients need sedation or even general anaesthesia, which increase unnecessary risk to the patients. This study is conducted to evaluate the benefit of popliteal sciatic nerve block or popliteal block compare to sedation in critical limb patients undergoing angioplasty.
Management of known patients with cardiovascular disease (in particular the whole spectrum of atherosclerotic ischaemic coronary artery disease, essential hypertension under treatment, and also patients with chronic heart failure under medication) and with other associated chronic pathologies, with obvious effects on the management of the pandemic with modern / distance means (e-Health) of patients at high risk of mortality in contact with coronavirus. Given the Covid-19 Pandemic, all the above complex cardiovascular patients are under the obligation to stay in the house isolated and can no longer come to standard clinical and paraclinical monitoring and control visits. Therefore, a remote management solution (tele-medicine) of these patients must be found. The Investigators endeavour is to create an electronic platform to communicate with these patients and offer solutions for their cardiovascular health issues (including psychological and religious problems due to isolation). The Investigators intend to create this platform for communicating with a patient and stratify their complaints in risk levels. A given specialist will sort and classify their needs on a scale, based on specific algorithms (derived from the clinical European Cardiovascular Guidelines), and generate specific protocols varying from 911 like emergencies to cardiological advices or psychological sessions. These could include medication changing of doses, dietary advices or exercise restrictions. Moreover, in those patients suspected of COVID infection, special assistance should be provided per protocol.