Clinical trials: Endovascular Procedure
Peripheral Artery Disease, Peripheral Vascular Disease
Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents
The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native…
- Trial name
- BIOFLEX-I (NCT01319812)
- Testing
- Astron Stents, Pulsar Stents
- Where
- 35 sites in United States, Canada
- Volunteers
- 463 people
- Sponsor
- Biotronik, Inc.
Aortic Dissection, Left Subclavian Artery Occlusion
Endovascular Repair With In Situ nEedle feNestration of Left Subclavian Artery to Treat AoRtic Dissection(RISEN STAR):A Multicenter Prospective Trial.
Background: Aortic dissection (AD) is a common emergency in vascular surgery, which seriously threatens human life and health. The rupture of Stanford type B dissection is located in aortic arch and the dissection range is from…
- Conditions
- Aortic Dissection, Left Subclavian Artery Occlusion, Vascular Diseases, Interventional Therapy
- Trial name
- NCT05186181
- Testing
- In situ fenestration
- Where
- China
- Volunteers
- 217 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Aortic Aneurysm and Dissection
A Prospective Study of Discomfort Symptoms in Patients With Aortic Disease After Endovascular Intervention
The incidence and severity of post-procedural discomfort were evaluated in patients undergoing endovascular repair for aortic disease across six symptom-related dimensions: immobilization-related issues, puncture site discomfort…
- Trial name
- NCT07114185
- Where
- China
- Volunteers
- 120 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Intraluminal Thrombosis, Tevar
Risk Factors, Incidence, and Clinical Impact of Intraluminal Thrombosis Following FET and TEVAR
Intraluminal thrombosis (ILT) is a significant but underexplored complication in aortic interventions. It is defined as the formation of thrombosis, partially or totally obstructing the lumen, in the surgically treated, stented…
- Conditions
- Intraluminal Thrombosis, Tevar, FET
- Trial name
- TRACE (NCT07492433)
- Where
- Italy
- Volunteers
- 800 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Stroke, Acute Ischemic, Endovascular Procedures
Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-2
The objective of this study is to create a comprehensive, real-world, multi-center observational registry of consecutive patients admitted to hospitals with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO), who…
- Conditions
- Stroke, Acute Ischemic, Endovascular Procedures, Large Vessel Occlusion
- Trial name
- TRACK-LVO-2 (NCT05659160)
- Testing
- Endovascular Therapy
- Where
- 4 sites in China
- Volunteers
- 5,000 people
- Sponsor
- Tianjin Huanhu Hospital
Iliac Artery Disease, Peripheral Artery Disease
AndraTec PMCF Study : Investigating the AndraTec Guidewires,PTA Balloons and Stents in Iliac Disease.
This PMCF study is designed as prospective, multi-center study to collect real-life data. The rationale of this study is to confirm and support the clinical safety and performance of the aforementioned products in 200 patients…
- Trial name
- NCT04822727
- Testing
- 1 or more AndraTec devices (see description for list of devices)
- Sponsor
- Dr. Sabrina Overhagen
Stroke
Direct Transfer to an Endovascular Center Compared to Transfer to the Closest Stroke Center in Acute Stroke Patients With Suspected Large Vessel Occlusion
To evaluate the hypothesis that direct transfer to an Endovascular Stroke Center, compared to transfer to the closest Local Stroke Center, offers a better outcome in the distribution of the modified Rankin Scale scores at 90 days…
- Trial name
- RACECAT (NCT02795962)
- Testing
- Direct transfer to an Endovascular Center
- Where
- 12 sites in Spain
- Volunteers
- 1,401 people
- Sponsor
- Fundacio Ictus Malaltia Vascular
Occupational Exposure to Radiation
New Fabric Attenuation Device in Endovascular Interventional Radiology II (PREFER II)
The PREFER II trial primary objective of the trial is to show how much radiation attenuation is provided by XPF thyroid collars in absolute and relative terms.
- Trial name
- PREFER-II (NCT01611454)
- Testing
- XPF thyroid collar, Standard 0.5mm lead equivalent thyroid collar
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Baptist Health South Florida
Percutaneous Closure of Artery Access Sites
InSeal Vascular Closure Device Clinical Study Protocol
The InSeal vascular closure device (VCD)is assessed as percutaneous closure of artery access sites for quick hemostasis and ambulation in patients who have undergone large bore endovascular catheterization procedures.
- Trial name
- VCD (NCT01896401)
- Testing
- InSeal's Vascular Closure Device
- Where
- Germany
- Volunteers
- 33 people
- Sponsor
- InSeal Medical Ltd.
Peri-operative Mortality
Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices
The aim of this study is to observe mortality and complications in procedures in which are used new generation low-profile endoprothesis.
- Trial name
- NCT04016545
- Testing
- Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Peripheral Vascular Disease
Luminor Registry: Registry of the Results of Angioplasty With Drug-eluting Balloon (Paclitaxel) in the Treatment of Infrainguinal Occlusive Lesions and Restenosis From Prior Endovascular Procedures in This Sector.
The purpose of the study is to obtain data regarding safety and efficacy of drug-eluting balloon luminor 14 \& luminor 35 in the treatment of infrainguinal occlusive lesions (superficial femoral artery (SFA), popliteal artery…
- Trial name
- NCT02458911
- Testing
- Paclitaxel-eluting balloon
- Where
- Spain
- Volunteers
- 214 people
- Sponsor
- iVascular S.L.U.
Peripheral Arterial Disease, Myocardial Injury
Cardiovascular Risk in Peripheral Artery Disease Patients Undergoing Endovascular Revascularisation
This study will investigate heart-related complications in patients with peripheral arterial disease (PAD) undergoing endovascular revascularization procedures to improve blood flow in the legs.
- Conditions
- Peripheral Arterial Disease, Myocardial Injury, Troponin, NT-proBNP
- Trial name
- RISK (NCT07599540)
- Where
- Slovenia
- Volunteers
- 500 people
- Sponsor
- University Medical Centre Ljubljana
Carotid Stenosis, Coronary Artery Disease
Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients
Prospective, single-center, clinical registry of patients with symptomatic/critical carotid artery stenosis at risk of stroke coexisting with unstable or multivessel severe coronary artery disease and/or severe valvular heart…
- Conditions
- Carotid Stenosis, Coronary Artery Disease, Valvular Heart Disease, Myocardial Infarction
- Trial name
- SIM-GUARD (NCT04973579)
- Testing
- Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- John Paul II Hospital, Krakow
Lesion; Femoral
Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant
In lower limb peripheral arterial disease, the stage of intermittent claudication has a prevalence of more than 5% over the age of 60, and affects patients who are often still active.
- Trial name
- PELI-CAN (NCT05216731)
- Testing
- Femoro-popliteal bypass, Endovascular procedure
- Where
- 16 sites in France
- Volunteers
- 290 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Endovascular Therapy, Neurological Complications
Nurse-Led Predictive Protocol Cuts Neuro-Endovascular Complications
The goal of this prospective cohort study was to develop and test a 12-item, nurse-led predictive checklist that can quickly identify patients at high risk for neurological complications (bleeding, re-blockage, brain swelling…
- Trial name
- NCT07304973
- Testing
- predictive checklist
- Where
- China
- Volunteers
- 426 people, healthy volunteers welcome
- Sponsor
- West China Hospital
Vascular Surgical Procedures, COVID-19
Outcomes of Vascular Surgery in COVID-19 Infection: National Cohort Study
There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery, specially vascular surgery.
- Conditions
- Vascular Surgical Procedures, COVID-19, Postoperative Complications
- Trial name
- Covid-VAS (NCT04333693)
- Testing
- Vascular surgery
- Where
- Spain
- Volunteers
- 50 people
- Sponsor
- Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Critical Lower Limb Ischemia, Abdominal Aortic Aneurysms
The Use of Carbon Dioxide as a Contrast Media for Performing Endovascular Procedures
Prospective randomized comparison between endovascular procedures performed with iodinated contrast or carbon dioxide as intraarterial contrast.
- Trial name
- NCT01861327
- Testing
- CO2, Iodine contrast media
- Where
- Brazil
- Volunteers
- 120 people
- Sponsor
- Nelson Wolosker
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
V-INTERVENTION will evaluate the effectiveness of inclisiran in preventing major cardiovascular and limb events in patients receiving percutaneous coronary or peripheral arterial revascularization.
- Trial name
- V-INTERVENTION (NCT06909565)
- Testing
- Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- Where
- 147 sites in United States
- Volunteers
- 6,000 people
- Sponsor
- Duke University
Aortic Dissection
Zenith® TXD Post-market Surveillance in Japan
The study is a post-market surveillance study required by Japanese Regulatory Authorities as a condition of approval
- Trial name
- NCT02663739
- Testing
- Zenith® TXD
- Where
- 27 sites in Japan
- Volunteers
- 57 people
- Sponsor
- Cook Group Incorporated
Peripheral Arterial Disease, Chronic Kidney Diseases
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
This research trial will test whether using carbon dioxide as a contrast medium during surgery to open blocked leg arteries can prevent kidney injury.
- Conditions
- Peripheral Arterial Disease, Chronic Kidney Diseases, Acute Kidney Injury
- Trial name
- KID (NCT07891988)
- Testing
- Iodinated contrast medium, CO2 automated injector contrast medium
- Where
- 6 sites in United Kingdom
- Volunteers
- 184 people
- Sponsor
- University of Leicester