Post-Market Registry to Evaluate the Safety and Efficacy of the The SUPRAFLEX CRUZ™ Sirolimus Eluting...
Coronary DiseaseProspective, multi-centre, open-label, single-armed, non-interventional observational clinical investigation designed to enrol 2000 octo- and nonagenerian all-comer patients with coro-nary artery disease in up to 37 sites in Germany, Switzerland and Austria. Patients underwent PCI using at least one Supraflex Cruz Sirolimus Eluting stent as per current practice and will be followed up for 12 months.
Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided...
AngioplastyCoronary Artery DiseaseOCT 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.
The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases
Heart FailureCoronary Artery Disease1 moreInvestigator-initiated, prospective, non-randomized, open label, non-interventional multicenter registry to evaluate current treatment of three major cardiovascular disease entities in clinical practice using a standardized variable-set of relevant covariates and outcome measures.
Myocardial Ischemia Without Obstructive Coronary Stenoses
Myocardial IschemiaNon-Obstructive Coronary Atherosclerosis3 moreCoronary-related myocardial ischemia can result from obstructive epicardial stenosis or non-obstructive causes including coronary microcirculatory dysfunction and vasomotor disorders. This prospective study has been created in order to provide knowledge in the field of non-obstructive coronary artery disease.
First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI
Atherosclerosis Coronary Artery With Angina PectorisAtheroscleroses4 morePatients will undergo intracoronary imaging using combined optical coherence tomography-fluorescence lifetime imaging (OCT-FLIm) during percutaneous coronary intervention, and the obtained imaging data will be used to assess the efficacy of this dual-modal catheter imaging strategy in characterizing high-risk plaque.
Outcome of Patients Treated With IABP
Acute Coronary SyndromeCardiogenic Shock5 moreIntra-Aortic Balloon Pumps (IABP) is a widely used and effective left ventricular adjuvant therapy. IABP is an inflatable device placed in the aorta that inflates with diastole and deflates with systole. The aim of this study is to investigate the outcome of patients treated With IABP, and to evaluate the short-term and long-term outcomes of patients with IABP.
Drug Coated Balloon for Side Branch Treatment vs. Conventional Approach in True Bifurcation Coronary...
Stable AnginaIschemic Heart Disease3 moreBifurcation lesions (BL) on coronary arteries account for 15-20 % of all performed percutaneous coronary interventions (PCI). Preferred approach for treatment of most bifurcation lesions is the stepwise provisional stent strategy with main branch-only stenting followed by provisional balloon angioplasty with or without stenting of the side branch (SB). Stenting of the side branch is indicated when the angiographic result in SB is clearly suboptimal and when flow remains reduced. Upfront use of two stent techniques may be indicated in very complex lesions with large calcified side branches ( most likely to supply at least 10% of fractional myocardial mass), with a long ostial side branch lesion (>5mm) or anticipated difficulty in accessing an important side branch after main branch stenting, and true distal LM bifurcations. From a technical point of view, we propose a "Provisional DCB approach" that differs from the standard provisional approach with obligatory SB predilation and good lesion preparation. In case of an adequate result of predilation, the procedure on the SB ends with the DCB deployment. This is followed by main branch stenting with DES, finished with POT. Final 'kissing' balloon dilation is generally not recommended because there is no advantage from final kissing with the one-stent technique. With this approach, there is no need for re-wiring, re-ballooning, side branching and wire jailing and final kissing. This technique is close to a contemporary approach to bifurcation lesions based on the fundamental philosophy of the European Bifurcation Club (EBC): keep it simple, systematic, and safe, with a limited number of stents that should be well apposed and expanded with limited overlap, with respect of the original bifurcation anatomy.
Contrast-associated Acute Kidney Injury in Patients With Different Types of Coronary Artery Disease...
Coronary Artery DiseaseAngina7 moreThe goal of the study is to assess the prevalence of contrast-associated acute kidney injury in patients with stable coronary artery disease, ST-elevation myocardial infarction and unstable angina/NSTEMI, assess the risk factors of contrast-induced acute kidney injury development and the influence of contrast-induced kidney injury on 1-year prognosis.
Safety and Efficacy of DCB Therapy for ISR Under the Guidance of QFR (UNIQUE-DCB-II Study )
Coronary Heart DiseaseIn 1970, the first percutaneous balloon coronary angioplasty opened a new chapter of interventional therapy. However, the incidence of intracoronary restenosis was about 30%. Subsequently, bare metal stents and drug-eluting stents (DES) reduced the incidence of in-stent restenosis (ISR) to 5%-10% and it was still a bottleneck treated by percutaneous coronary intervention (PCI). Currently, ISR is mainly treated by balloon angioplasty, stent implantation and coronary artery bypass grafting. In 2014, the guidelines of the European Society of Cardiology recommended that drug balloon therapy (DCB) and new generation DES should be the preferred strategies for ISR treatment. Compared with DES, DCB treatment can avoid the inflammation of intima caused by multi-layer stent strut, and reduce the risk of intimal hyperplasia and thrombosis in stent. However, DCB lacks sustained radial support. Even if the residual stenosis is less than 30% after sufficient pre-dilation, the elastic retraction of the intima still exists. In addition, the antiproliferative effect of paclitaxel is significantly worse than that of sirolimus and its derivatives, and there is a lack of long-term sustained release of anti-proliferative drugs. Compared with DCB, DES can obtain long-term stable radial support and long-term anti-proliferation effect, but stent struts exposed in the vascular lumen are at risk of stent thrombosis. The new generation of DES improves the design of stent platform, improves the polymer coating, and applies new anti-proliferative drugs. It effectively reduces the inflammation of vascular wall, speeds up the process of vascular re-endothelialization, promotes early vascular repair, and significantly reduces the incidence of stent thrombosis. Recent BIOLUXRCT, RESTORE and DARE studies provide more powerful evidence for the treatment of ISR by new generation DES. Quantitative flow ratio (QFR) is the second generation FFR detectional method based on coronary contrast image. The latest FAVOR II results also confirm that QFR is more sensitive and specific than quantitative coronary analysis (QCA) in the diagnosis of myocardial ischemia caused by coronary artery stenosis. However, there is no report of ISR treated with DCB under the guidance of QFR. The aim of this study was to evaluate the safety and efficacy of DCB in the treatment of in-stent restenosis in patients with coronary heart disease (CHD) under the guidance of QFR compared with DES implantation.
Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk Patients...
Ischemic Heart DiseaseAtrial FibrillationPreliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation. Uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists. The investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (HBR) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.