View clinical trials related to Coronary Occlusion.
Filter by:The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real world practice in Japanese hospitals.
The aim of this CTO registry is to gather data including patient demographic date, cardiac risk factors, procedural technical data and procedural success/outcome rates. Furthermore, we aim to evaluate the safety and performance of various CTO specific guidewires, devices (such as the CrossBoss/Stingray dissection re-entry device) and other recognised and approved techniques (retrograde wire escalation, retrograde dissection re-entry techniques). The incidence of recognized complications (dissections, perforations, cardiac tamponade, vascular complications, radiation injury, acute kidney injury) will also evaluated. The investigator will assess clinical outcome at 1 year after successful CTO procedures.
DebriS Interventional REmoval in ACS (DESIRE-ACS) Study to assess the safety and performance of the ECA Bell balloon in subjects undergoing coronary percutaneous interventions.
Clinical trial phase III, prospective, controlled, randomized, open. We hypothesize work that patients with chronic coronary occlusion and poor myocardial viability who failed to recover ventricular function after subjecting coronary revascularization with new techniques of recanalization, could achieve an improvement of ventricular function if given further regenerative treatment with mononuclear cells from autologous bone marrow. To test this hypothesis we designed a prospective, randomized clinical trial in patients with recanalized chronic occlusions and ventricular dysfunction.
Wire-crossing of a chronic total coronary occlusion (CTO) is time-consuming and limited by the amount of contrast agent and time of radiation exposure. Magnetic wire navigation might accelerate wire-crossing by maintaining a coaxial vessel orientation. This study compares magnetic with conventional wire navigation for recanalization of CTOs.
CTOs are common among patients with angina, and are detected in around 20% of patients undergoing coronary angiography. Treatment of CTO has been found to constitute only 7% of PCI practice on average. One of the reasons for the under-presentation of CTOs in PCI target lesions is the lack of evidence-based medical data on treatment indications, and the continued low level of accepted evidence for the treatment of CTOs by PCI in PCI guidelines. Patients with a CTO represent patients with stable coronary artery disease. The COURAGE trial comparing PCI with optimal medical therapy in stable coronary disease did not show a difference in mortality or myocardial infarction between the two treatment options. However, CTOs were not included in the COURAGE trial. But that trial did confirm the superiority of PCI over OMT in controlling symptoms of angina, with a high cross-over rate to PCI. Whether PCI for CTO is superior to OMT in reducing MACE in those patients with a large ischaemic burden has never been tested in a randomized controlled trial. While there is compelling evidence from registry studies of a clinical and prognostic benefit following successful PCI of CTO compared with PCI failure, there has been no randomized controlled trial of contemporary PCI using drug-eluting stents versus optimal medical therapy. The COURAGE trial nuclear sub-study confirms both that prognosis is closely related to the extent of residual ischaemia and that PCI is more effective in reducing residual ischaemia than optimal medical therapy alone. This confirms earlier retrospective data suggesting that the benefit of PCI is greatest in patients with moderate (10-20%) or severe (>20%) ischaemia. Study hypothesis: PCI with Biolimus eluting stent implantation plus OMT will be superior to OMT alone in improving health status at 12-month follow-up, and will be noninferior with respect to the composite of all cause death/ non fatal MI at 36-month follow up, in patients with a CTO in an epicardial coronary artery >2.5 mm diameter and chronic stable angina with evidence of ischemia and viability in the territory subtended by the CTO
ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to: - Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily PCI practice per Instructions for Use (IFU, on-label use). - To evaluate the safety and performance of 12 mm or shorter Absorb BVS in single or overlapping use (bailout, optimization of long lesion treatment) for the treatment of patients with ischemic heart disease caused by de novo native coronary artery lesion(s) - Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation.
Percutaneous recanalization of total coronary occlusions (TCO) was historically hampered by high rates of restenosis and reocclusion. In the PRISON II and III trial we showed landmark reduction in restenosis with sirolimus-eluting stents (Cypher, Cordis Corporation) compared to conventional bare metal stents in TCO. In the PRISON III trial, we observed similar favourable results with second-generation zotarolimus-eluting stent (Resolute, Medtronic Inc.). Another drugs-eluting stent mounted with everolimus (Xience Prime, Abbott) also demonstrated favourable results in TCO. Recently, drug-eluting stents (DES) with bioresorbable polymer coatings were developed, to address safety concerns regarding the observation of very late stent thrombosis, due to hypersensitivity reactions, and chronic inflammation, on the durable polymer coating of DES. However, none of these DES with bioresorbable polymers were evaluated in patients with TCO. The PRISON IV trial is a prospective, randomized, single-blinded, multi-center trial, designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (ORSIRO, Biotronik Inc.) compared to everolimus-eluting stents with durable polymers (Xience Prime, Abbott) in patients with successfully recanalized TCOs.
During fluoroscopic imaging, diagnostic information is carried in the primary beam. These high intensity X-rays are the chief hazard to the patient. Lower energy scattered radiation deviates in all directions from the patient. Despite typical precautions (i.e., hanging a lead shield between the patient and the operator), many operators will be exposed to high radiation dose (higher than the permitted 50 miliS per year), this long term radiation exposure may result in stochastic and deterministic effects. The purpose of this study was to test the hypothesis that a non disposable radiation protection drape (that will cover the lower part of the patient) could help minimize the radiation scattered from the patient to the operator. In a procedure done through the Radial approach, there is a large portion of the patients (from the umbilicus and down) that is a source of scatter radiation to the operator. This portion can be covered with a lead rectangle. A non disposable, lead drape of uniform thickness will be inserted into a sterile nylon bag and will be used during fluoroscopic and cineangiography coronary angioplasty procedures. The lead drapes will cover the femoral puncture site. The widths and length of the drape is 50-60cm and 100 cm respectively and was shown not to hinder the field of radiation needed for fluoroscopy and cineangiography. (The upper border of the lead is under the patient's umbilicus and was shown not to interfere with the radiation field needed for angiography or angioplasty). The Investigators anticipate that the study will show a significant reduction in radiation exposure and hence reduce the radiation hazard to the operator.