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Showing 1-19 of 19 trials
NCT07473596
The goal of this clinical trial is to describe the long-term (≥ 3 years) patency of coronary artery stents following chronic total occlusion percutaneous coronary intervention (CTO PCI). The main questions it aims to answer are: * What is the incidence of in-stent restenosis after CTO PCI? * What are patient-, lesion-, and procedure-related factors associated with an increased risk of in-stent restenosis after CTO PCI?
NCT06543641
The goal of this clinical trial is to assess third-generation dual-source coronary computed tomography angiography (CCTA) performance in the evaluation of long coronary stents in patients with coronary artery chronic total occlusions. The main questions it aims to answer are: * Can patency of long coronary artery stents be assessed with third generation CCTA? * What are the factors affecting the assessability? * What is the radiation exposure of third generation CCTA?
NCT05813704
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary crossing system for the treatment of patients with coronary chronic total occlusions.
NCT03475888
A chronic total occlusion (CTO) is common in patients with coronary artery disease. CTO recanalization has been shown to improve survival in comparison to failed CTO recanalization. Whether this is related to ventricular arrhythmias (VA) is unknown. The purpose of this pilot study is to evaluate the incidence of VA after successful CTO recanalization and in those with failed CTO recanalization or untreated CTO. Patients will be monitored using an insertable cardiac monitor.
NCT04881812
This is an investigator-initiated, randomized, multi-center, non-inferiority clinical trial. Patients with a Chronic Total Occlusion who are eligible for PCI will be randomized to additional Drug-Coated-Balloon treatment or stenting of adjacent residual disease to the CTO body. The aim of this study is to investigate whether treatment with DCB is non-inferior to complete stenting of the CTO body.
NCT05883579
Studying the prediction ability of different CTO scoring systems on Asian CTO PCI population with their relation to technical success and developing a newer stepwise approach depending on these CTO scoring systems for choosing the suggested successful approach considering collateral channel assessment.
NCT04944615
This study aims to evaluate the treatment of Chronic total occlusion (CTO) disease. Whether Intravascular Ultrasonography (IVUS) guiding the implantation of drug-eluting stents (DES) will provide better long-term clinical outcomes compared with conventional angiography
NCT03947398
The purpose of this study is to investigate the effectivness of the Blimp Scoring balloon compared to current available CTO balloon catheters.
NCT03769038
BACKGROUND：Chronic total occlusion (CTO) angioplasty is one of the most challenging procedures remaining for the interventional operator. Today, with contemporary CTO negotiation available strategies and significant operator expertise, the literature reports a 50%-95% success rate for recanalizing CTOs. But PCIs of CTO lesions still carry a high rate of in-stent restenosis (ISR). Because previous reports have not specifically compare contemporary antegrade and retrograde dissection and re-entry dissection (ADR/RDR) technique on the long-term impact of ISR, so the investigators focused on the objective. OBJECTIVES: This study hope to evaluate the frequency of angiographic ISR and further elucidate some ISR related higher risk factors among CTO PCI patients in intimal stent group using antegrade or retrograde wire escalation (AWE/RWE) techniques and sub-intimal stent group using contemporary antegrade or retrograde dissection and re-entry (ADR and/or RDR). METHODS: A total of 300 consecutive selected patients with CTO lesion who will undergo successful revascularization by AWE/RWE and ADR/RDR techniques treatment will be enrolled in this prospective multicenter registry from December 1 2018 to December 31 2019. The primary study endpoint of the protocol is the bionary in-stent restenosis of CTO vessels at angiographic follow-up about 13 months. The secondary endpoints are: 1) CTO technique and procedure success rate; and 2) in-hospital and 30 days MACE (Cardiac death, acute myocardial infarction, urgent repeat tratget vessel revascularization with either pericardiocentssis or surgery and stroke and stent thrombosis and stroke); 6months and 1-year and 2-year MACE including death, MI, and target CTO vessel revascularization and stroke ; and 3) Restenosis scores (R-scores) of related risk factors.
NCT03988166
The objective of this study is to evaluate angiographic confirmation of placement of any guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used.
NCT05205148
ULTRA is a multicenter, observational, retrospective registry, enrolling consecutive patients treated with ultrathin coronary DES (coronary stent with strut thickness \< 70 um) for coronary bifurcation lesions, left main disease, chronic total coronary occlusion, and in-stent restenosis regardless of their clinical presentation. Target lesion failure (TLF a composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis) will be the primary end point, while its single components will be the secondary ones along with all-cause death, all acute myocardial infarction (excluding peri-procedural AMI), target vessel revascularization and BARC major bleedings (BARC 3-5). Due to the retrospective, observational nature of the registry, no formal sample size estimation is required. Patients complying with detailed inclusion criteria and with a minimum follow up of 6 months will be enrolled.
NCT04965207
IVUS will be used to evaluate the ratio of false lumen to occluded segment, the ratio of false lumen to stent length, the location characteristics of false lumen and its prognostic value for perioperative complications, 1-year late lumen loss and MACCE events in patients with coronary CTO.
NCT04744571
The purpose of this study is to investigate the safety and efficacy of drug-coated balloon angioplasty for the treatment of chronic total occlusions patients with chronic total occlusion (CTO) lesion.
NCT04650139
The aim of the proposed project is to provide the long-term results after a recanalization attempt of chronically occluded coronary arteries. To investigate recanalization attempt of chronically occluded coronary arteries at the Ulm University Hospital. As shown, it is known that successful recanalization of a chronic occlusion is associated with a lower event rate (reduced mortality and the need for operative myocardial revascularization) compared to unsuccessful recanalization (drug therapy). The standard in the therapy of successfully recanalized chronic occlusions is the use of drug-releasing vascular supports.
NCT03118544
The is an observational, prospective study to evaluate the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)
NCT02477579
This study evaluates the safety and effectiveness of the a novel device called NovaCross to help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.
NCT02075372
The successful re-opening of a blocked coronary artery has a beneficial effect on the further clinical course (e.g. improvement of clinical symptoms, improved quality of life, increased heart function, etc.). However, some types of blockages are more difficult to open by means of percutaneous coronary intervention (PCI), a procedure which is commonly used for these kind of problems. This procedure makes use of a technique in which special wires, balloons, stents (metal or polymeric tube-like structures) and devices are utilized to re-open or revascularize a blockage in one of the blood vessels of the heart. This type of blockages are chronic total occlusions (CTO). CTOs have certain characteristics which impede the revascularization of the blood vessel. Nevertheless, remarkable progress has been achieved over the past few years in the area of CTO revascularization or CTO PCI. A large range of CTO dedicated materials, such as guidewires, guiding catheters, devices, balloons and stents, as well as different techniques have been developed. However, at present, reluctance to open CTOs still exists, due to the indications and outcomes of percutaneous revascularization as well as the technical difficulties which commonly arise during these interventional procedures. The presence of these difficulties results in suboptimal success rates worldwide (±70-80%), despite these many innovations. To increase these success rates and to make sure more interventional cardiologists will treat CTOs, a hybrid treatment algorithm has been developed with the materials (e.g. CrossBoss™ catheter; Bridgepoint Medical, Inc.) and techniques, currently already available. The main purpose of this study is to evaluate the efficacy and efficiency of this hybrid algorithm as well as validating the efficacy of one of the materials (CrossBoss™ catheter), used in this algorithm. To be able to do this, data concerning the patients' demographics, CTO characteristics, procedure and outcome will be collected in the form of a registry. This registry will be performed in several European centra (Belgium, the Netherlands, United Kingdom, France). Since the study will only collect data and no intervention is performed, this will be an observational study. At regular time points, the data will be checked for errors or inconsistencies. To do this, site visits will be performed at pre-defined times.
NCT01759290
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 percutaneous coronary intervention (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.
NCT02360020
Stent delivery failure occurs in 4% of all percutaneous coronary interventions (PCI) and \>90% of these failures are due to vessel tortuosity and/or calcification. The XLIMUS eluting coronary stent (CARDIONOVUM GmbH, Bonn, Germany) is a new type of endovascular prostheses characterised by better mechanical properties than traditional DES. This is a prospective, non-randomized, single-center pilot study, aiming to evaluate the performance of the XLIMUS DES in severely complex coronary lesions in real-world clinical practice.