Clinical Research Directory

Lymphatic Injury Visualization in Vascular Surgery

This study aims to assess a simple intervention: Visualization of lymphatic injury + treatment (in case of detection). This will generate data on the incidence of intraoperative lymphatic injury and the effect of treatment. This data will then hopefully enable a multi-center RCT to generate high level evidence on this matter.

Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors

The study is observational and involves patients (pts) with peripheral arterial occlusive disease (PAD) who have undergone lower limb revascularization procedures. Patients who are at least one year post-procedure will be contacted by phone and asked whether any cardiovascular complications occurred during that period, specifically major adverse cardiovascular events (MACE) or major adverse limb events (MALE), and whether they had been taking sodium-glucose co-transporter 2 inhibitors (SGLT2-i, "flozins") during the year following the procedure. The results from the group of pts who, for any reason, received SGLT2-i treatment after the vascular procedure (including those who had initiated treatment before surgery) will be compared to the results from the group of patients who did not receive such treatment, with regard to the occurrence of the aforementioned complications.

Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)

The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.

Assessment of Revascularization in Plantar Foot of Diabetic Patients Pre and Post Angioplasty Using Spatial Frequency Domain Imaging

To explore the usefulness of SFDI in the assessment of revascularization pre and post intervention

Iliac Stent-Grafts in TASC C-D Lesions

This study aims to evaluate the midterm outcomes of patients with advanced aortoiliac artery narrowing (TASC C-D lesions) who were treated with covered iliac stent-grafts instead of open surgery. These patients were either too high-risk for surgery or refused it. Medical records from the past five years at a single cardiovascular surgery center in Turkey were reviewed retrospectively. The research focuses on the success rate of the procedure, complications, vessel patency, and the need for additional treatments. The results may help guide treatment decisions in similar high-risk patients who are not candidates for open vascular surgery.

Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)

The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase III clinical study to treat their critical limb ischemia (CLI). The main questions it aims to answer are: * First, what medical problems do participants have after taking drug NL003 to treat CLI? * Second, does drug NL003 make CLI participants live longer without serious problems (amputations or target vessel revascularizations) ? Participants who have already received drug NL003 for CLI will complete online surveys about their health conditions. This study will continue until at least 36 months after the participant's first dose.

Transverse Versus Longitudinal Groin Incision in Vascular Surgery

The purpose of the study is to examine whether incision type has an influence on the development of groin wound complications after operation in the groin in vascular surgery. The main questions it aims to answer are: Does a transverse incision in the groin lead to fewer surgical site complications than a longitudinal incision? Does a transverse incision lead to fewer readmissions, fewer reoperations, shorter length of hospital stay, and a lower amputation rate. Participants will undergo vascular surgery in the groin with either a transverse or longitudinal incision. The incision type will be selected randomly.

Intravascular Ultrasound for Peripheral Artery Disease Revascularization

The purpose of this study is to determine if IVUS use, as compared to angiography alone, prevent major adverse limb events (MALE) or binary restenosis (a greater than 50% re-narrowing of the treated artery) in adult patients who have CLTI and are undergoing percutaneous revascularization.

Korean Vascular Intervention Society Multicenter Registry Study on Outcomes of Endovascular Therapy in Lower Limb Artery Diseases (K-VIS ELLA): (A Retrospective & Prospective Observational Study)

1. Study design: multicenter retrospective and prospective observational study 2. Study Cohort : 1. Retrospective cohort: This cohort retrospectively enrolls patients with lower extremity artery disease who underwent endovascular treatment from January 2006 to the date of approval by IRB in the participating hospitals. Informed consent was waived by IRB. 2. Prospective cohort: This cohort prospectively enrolls patients with lower extremity artery disease who undergo endovascular treatment from the date of approval by IRB to July, 2018 in the participating hospitals. Informed consent will be obtained prior to enrollment. 3. Baseline clinical and lesion characteristics, procedural and post-procedural data, clinical outcomes, hemodynamic, and imaging follow-up data are investigated. Primary patency and target lesion revascularization rates of the total cohort and patient subgroups are evaluated. Risk factors of restenosis and target lesion revascularization are determined.

Effect of Anticoagulant and Antiplatelet Drug Intervention on Postoperative Major Adverse Events in Patients with PAD：Phase II

This study is a multicenter, prospective, observational research project. It is anticipated to enroll a total of 6,000 patients between February 1, 2025, and January 31, 2028 (with completion of one-year postoperative follow-up by January 31, 2029). Patients will be grouped according to different combinations of anticoagulant and antiplatelet drugs used postoperatively for PAD. The types, dosages, and duration of postoperative anticoagulant and antiplatelet drug use will be recorded. Follow-up assessments will be conducted at 1 month, 6 months, and 12 months postoperatively to document the occurrence of Major Adverse Cardiovascular Events (MACE) and Major Adverse Limb Events (MALE) in the enrolled patients.

Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)

The purpose of this study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications for endovascular peripheral interventions of femoral, popliteal and infrapopliteal lesions.

Effects of Virtual Reality Exercises on Individuals With Peripheral Artery Disease

The aim of this study is to investigate the effects of virtual reality exercises on lower extremity skin temperature, arterial stiffness, gait parameters and enjoyment of exercise in individuals with peripheral arterial disease.