Peripheral Artery Disease (PAD)

A two-center, randomized, double-blind, placebo-controlled, dose-escalation IIT clinical study evaluating the safety and preliminary efficacy of injectable IMC-001 in improving atherosclerotic plaque stability in patients with acute coronary syndrome. The plan is to conduct 2 dose groups, with 9 subjects enrolled in each group, including 6 in the treatment group and 3 in the control group. The treatment group will receive IMC-001 along with optimal drug therapy, with a total of 12 subjects included, while the control group will receive a placebo along with optimal drug therapy, with a total of 6 subjects included.

PeriPREVENT is a prospective, multi-centre, controlled, open-label, 1:1 randomized superiority trial with two parallel groups. In the intervention group patients will undergo a routine peripheral angiographic intervention (PVI) using a maximally contrast medium sparing strategy with an automated CO2 injection system including iodinated CM as bailout option in case of insufficient image quality or patient's intolerability of CO2 angiography. The control intervention is routine PVI using iodinated contrast media (CM) as standard of care. All patients are followed up until 12 months after the PVI.

The therapy being trialed in this study uses motor learning theory to try and improve or change walking patterns to improve the child/teen's walking goal. Therapy will target their own walking goal and they can choose the format of their therapy as long as they complete 30 hours of which 24 hours must be in the clinic within a 6 week period.

Cardiovascular disease is a major threat to the health of Chinese residents, and echocardiography, as its core diagnostic tool, directly affects clinical decision-making in terms of measurement accuracy and efficiency. However, traditional ultrasound evaluation heavily relies on physician experience, with pain points such as strong subjectivity, time-consuming measurements, and uneven levels of primary diagnosis. There is an urgent need for technological innovation to improve diagnostic standardization. In recent years, artificial intelligence (AI) technology has shown great potential in the field of medical image analysis, which can achieve automated quantitative measurement of cardiac chamber structure and function. However, existing AI models generally have problems such as insufficient multi center validation and limited adaptability to complex cases, which restrict their clinical translation and application. To overcome these bottlenecks, this project collaborates with multiple medical institutions to conduct clinical research, systematically evaluating the measurement differences between AI algorithms and physicians of different levels, and assessing the accuracy and stability of AI algorithms. The research will focus on verifying the value of AI technology in improving diagnostic consistency, optimizing workflows, and exploring its potential applications in complex cardiovascular diseases. By establishing a standardized evaluation system, this project aims to promote the standardized application of AI ultrasound technology, ultimately achieving the goal of improving diagnosis and treatment efficiency, promoting the sinking of high-quality medical resources, and helping to improve the overall level of cardiovascular disease prevention and treatment.

In this study, patients who receive a Vascular Graft for the treatment of arterial diseases (aneurysm, PAU, IMH, dissection, stenosis) of the aorta or peripheral arteries (lower limbs) or as an AV shunt will be observed. This includes patients in whom the Vascular Grafts are used for debranching or reconstruction of the head vessels. Participating physicians will be asked to provide the observations, that were collected during routine care. Written informed consent, specifically allowing the use of clinical records for this observational study, will be obtained from every patient prior to data collection. The period of data collection will be approximately 60 + 6 months (depending on the date of the last follow-up visit) from the date of intervention for each patient.

A preventive, multidisciplinary primary care intervention organized around a therapeutic garden: Acceptability to patients suffering from cardio-neurovascular pathology and to those involved in the action.

In the last years, most of the technical evolution of materials dedicated to the treatment of femoropopliteal disease has been focused on drug-eluting technologies. However, in very complex lesions drug-coated balloons seems to be less efficient, leading to a high rate of bailout stenting with bare metal stents. Drug-eluting stents have raised expectation, providing structural scaffolding of the artery and active pharmacological treatment of the target lesion. Available evidence from the literature does not always seem to support this hypothesis. Still, a lot of rumours have been generated on the potential local and systemic toxicity of paclitaxel. As a consequence, in complex lesion rather than Drug Coated Balloon and Drug Eluting Stent it seems that there is need of a modern generation of nitinol stents with high Radial Resistive Force, low chronic outward forces and high fracture resistance. The device under investigation is the Renzan™ Peripheral Stent System from Terumo MicroVention Inc. (35 Enterprise, Aliso Viejo, California 92656, USA) . The System consists of a self-expanding nitinol stent pre-mounted on the distal portion of a rapid exchange (RX) delivery catheter. The stent is made of a nickel-titanium alloy with radiopaque markers on each end of the stent. The nitinol stent is constructed from 2 layers of tubular braided nitinol wire mesh. The outer layer consists of nitinol wire braided into a closed cell structure with flared ends. The inner layer consists of nitinol wire braided into a closed cell structure with micro sized pores. The delivery catheter has a rapid exchange port designed to allow coaxial passage of a 0.46mm (0.018") or smaller guide wire in diameter. The stent is capable of being recaptured when a minimum of 20mm of stent length remains inside the catheter.

The OPTIMAL Trial is a prospective, multicenter, randomized controlled study evaluating whether a coronary CT angiography (CCTA)-guided calcium modification strategy can improve the treatment of patients with hemodynamically significant, calcified coronary artery disease undergoing percutaneous coronary intervention (PCI). Seven hundred patients with flow-limiting stenosis (FFRCT ≤0.80) and moderate-to-severe calcification on CCTA will be randomized 1:1 to either CCTA-guided or intravascular ultrasound (IVUS)-guided calcium modification. The study includes two co-primary endpoints: (1) superiority in final minimal stent area assessed by IVUS, and (2) non-inferiority in 12-month target vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven revascularization). CCTA-guided strategy uses advanced calcium characterization to inform pre-procedural planning and selection of plaque modification techniques. IVUS-guided strategy follows contemporary intravascular imaging-based criteria for plaque preparation and PCI optimization. The trial aims to determine whether leveraging non-invasive CT-based calcium assessment can enhance procedural efficiency and stent results while maintaining clinical safety comparable to IVUS-guided PCI.

WOUNDJOURNEY is a longitudinal, real-world observational registry focused on the chronic disease burden and patient journey of individuals with chronic wounds and ulcers. Data collection began in 2005 and continues prospectively, capturing structured clinical data at the point of care using a purpose-built certified EHR or EDC system. These data are securely transmitted to the U.S. Wound Registry (USWR), a CMS-designated Qualified Clinical Data Registry (QCDR). All major wound types are represented: Diabetic foot ulcers (DFUs), diabetic ulcers not on the foot, Venous leg ulcers (VLUs), Arterial ulcers, Pressure ulcers/injuries, Surgical complications, Traumatic wounds, Vasculitic/inflammatory, and sickle cell-related ulcers, and chronic non-pressure ulcers. The registry collects detailed data on standard-of-care practices and advanced wound care interventions, including brand-specific information on: Advanced dressings (e.g., collagen, antimicrobial), Compression therapy, Offloading devices, Cellular and/or tissue-based products (CTPs) also called Cellular, Acellular, or Matrix-like Products (CAMPs) or "skin substitutes," Negative pressure wound therapy, MIST therapy (low-frequency ultrasound), Topical oxygen therapy (TOT), Hyperbaric Oxygen Therapy (HBOT), Topical growth factors (e.g., Becaplermin), Enzymatic and mechanical debridement, Fluorescent imaging for bacterial load, Topical antibiotics and antimicrobials, and other treatments. The registry captures key elements of the patient journey, including: Frequency of debridement, Sites of care, number of patient visits and number of wound visits, Dressing changes, Use and timing of advanced therapies, Comorbid disease burden and clinical complexity, Patient Frailty, number of wounds and ulcers per patient, patient time in service, wound time service, patient and wound outcomes, the development of new wounds while in service and complication rates. Wounds are risk stratified using the Wound Healing Index, enabling case-mix adjustment and longitudinal outcome tracking. Follow-up may extend over five years, capturing outcomes such as: Complete healing (epithelialization), Non-healing, Major and minor amputations, Mortality, and Loss to follow-up or transfer of care. Quality of care is assessed using wound-specific quality measures. The registry integrates real-world clinical care with research and quality improvement, supporting a learning healthcare system model. Through secure tokenization, registry data may be linked to payer claims for comprehensive longitudinal analysis of healthcare utilization, interventions, hospitalizations, medication use, and long-term outcomes across care settings. This enables rigorous, policy-relevant evaluations of standard care and advanced wound therapies in routine practice. The robust patient and wound level data are suitable to understand the natural history of chronic wounds and ulcers and to create historical controls for prospective clinical trials.

The investigation is a prospective, multi-center, single arm clinical study. The trial is anticipated to last from December 2022 to December 2030 with 1000 subjects recruited in around 50 Chinese centers. The population for this study is subjects with intracranial atherosclerotic stenosis who are suitable candidates for stent angioplasty. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after they signed the informed consent form. The study consists of ten visits including preoperative screening, operation date, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years. The primary outcome was a composite of stroke or death within 30 days or any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after operation.