Active clinical trials for "Coronary Restenosis"

STAR is a minimal-risk pragmatic clinical trial of patients admitted for a CTO-PCI procedure. The overall objective of the STAR Study is to address the current gaps in knowledge regarding use of STAR during CTO-PCI, as a prospective, multi-center study of 150 participants with randomization of timing of staged PCI. Five sites will be selected to participate in STAR from a national network of highly experienced CTO-PCI centers across the United States.

The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis.

Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal or drug-eluting coronary stent will be randomized 1:1 to treatment with either the SELUTION SLR™ DEB or SOC to include contemporary DES (zotarolimus-eluting stents and everolimus-eluting stents only) or non-DEB BA. A maximum of 418 randomized subjects will be included. Subjects will be followed for 5 years post-intervention. Primary endpoint will be target lesion failure (TLF) determined at 12-month clinical follow-up.

BACKGROUD: Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis. Protected LM PCI is considered standard of care in most centers. OCT allows for precise determination of stent placement, stent expansion and apposition. The pattern of vessel healing can be very precisely studied if immediate post-stent implantation OCT/IVUS data is compared to the 6-month post-PCI interval. While OCT cannot be optimally used for ostial lesion imaging, IVUS can be used to image ostial lesions/stent placement. Optimal and consistent vessel healing is particularly important in LM PCI where stent thrombosis is a potential complication with serious adverse outcome. HYPOTHESIS: Due to the absorption of the polymer of the Boston Scientific Synergy Stent over time, early strut coverage patterns and timeline may be different than previously observed in DES and BMS stents in LM PCI. Late acquired stent malapposition (LASM) is expected to differ from previous observations with traditional DES/BMS. Stent coverage in LM PCI will be studied with OCT or IVUS at six and 12 months and compared to OCT or IVUS at the time of stent implantation. OCT/IVUS data will be analyzed in a core lab (CRF) and correlated with clinical outcomes at 6 and 12 months.

Despite optimal angiographic result after stent implantation, a number of patients will undergo repeat angiography within 1 year of index procedure. EASY-PRIPCI is an observational study evaluating the incidence of abnormal physiology results in patients undergoing repeat angiography after uncomplicated percutaneous intervention (PCI).

The purpose of the SIROOP Registry is to retrospectively and prospectively collect baseline, clinical and procedural characteristics of patients who have undergone PCI and are treated with either currently available sirolimus or paclitaxel coated DCBs (see Table 1), irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. Outcomes will be compared in different clinical subgroups. The impact of current DCBs in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

This is a self-controlled cohort study to evaluate the efficacy and safety of comprehensive treatment in patients with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD) by comparing the study endpoints before treatment with those after treatment in the same group of patients.

The purpose of the COMPLEX Registry is to prospectively and retrospectively collect baseline, clinical and procedural data of patients who have undergone PCI or CABG for complex and/ or calcified chronic CAD, irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. The outcomes will be compared in different clinical subgroups (e.g. PCI vs. CABG). The impact of current PCI techniques/ devices, but also CABG strategies in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.

Evaluate angiographic performance in long lesions of Sirolimus Eluting Balloon Magic Touch by Concept Medical