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.
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.
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.
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 Artery Disease, Access Site Complication
BIOTRONIK 4French for AMBulatory Peripheral Intervention
BIOTRONIK 4French for AMBulatory peripheral intervention. A multicenter, controlled trial comparing 4French versus 6French femoral access for endovascular treatment of lower-extremity peripheral artery disease in an ambulatory…
- Conditions
- Peripheral Artery Disease, Access Site Complication, Outpatient Treatment
- Trial name
- BIO4AMB (NCT03044002)
- Testing
- Biotronik 4 French Portfolio, 6 French Portfolio
- Where
- 5 sites in Austria, Belgium and 2 more
- Volunteers
- 821 people
- Sponsor
- Biotronik AG
Percutaneous Closure of Artery Access Sites
InSeal VCD Large Bore Vascular Closure Device Safety and Effectiveness Clinical Study
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
- InSealVCD (NCT02628782)
- Testing
- InSeal's Vascular Closure Device
- Where
- 2 sites in Israel
- Volunteers
- 16 people
- Sponsor
- InSeal Medical Ltd.
Surgical Wound
The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.
- Trial name
- Closer (NCT02136004)
- Testing
- Closer VSS
- Where
- 12 sites in United States
- Volunteers
- 220 people
- Sponsor
- Rex Medical
Ruptured Aneurysm
European, Multi-center, Exploratory Trial to Assess WEB Versus Other Endovascular Treatment in Ruptured Aneurysms.
Comparison of efficacy and safety between WEB and other endovascular techniques
- Trial name
- WAVE (NCT06511245)
- Testing
- Randomisation
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Microvention-Terumo, Inc.
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Peripheral Arterial Disease
The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)
The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial…
- Trial name
- GREAT (NCT06321575)
- Testing
- Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS)
- Where
- 20 sites in United States
- Volunteers
- 159 people
- Sponsor
- Nipro Vascular Innovations Americas, Inc
Venous Vascular Closure
Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression
ReliaSeal is a clinical trial designed to evaluate safety and efficacy of use of MYNX CONTROL™ Venous Vascular Closure Device 6F-12F vs.
- Trial name
- ReliaSeal (NCT05554471)
- Testing
- MYNX CONTROL™ Venous Vascular Closure Device 6F-12F
- Where
- 14 sites in United States
- Volunteers
- 352 people
- Sponsor
- Cordis US Corp.
Acute Anterior Myocardial Infarction
Rapid Intravascular Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Intervention
Rapid MI-ICE-Pilot is designed to demonstrate the safety and efficacy of the Celsius Control™ System (CCS) endovascular catheter to reduce the infarct size resulting from acute anterior myocardial infarction when used in…
- Trial name
- NCT00417638
- Testing
- Endovascular cooling by the Celsius Control System, Standard of care
- Where
- Sweden
- Volunteers
- 20 people
- Sponsor
- ZOLL Circulation, Inc., USA
Vascular Closure, Endovascular Procedure
Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study
The study aims to further demonstrate the safety and effectiveness of the FemoSeal™ VCS in achieving hemostasis following percutaneous endovascular procedures performed via the common femoral artery (CFA) access site.
- Conditions
- Vascular Closure, Endovascular Procedure, Hemostasis, Peripheral Vascular Disease
- Trial name
- FEMOSEAL CLOSE (NCT05027698)
- Where
- 3 sites in Belgium, France and 1 more
- Volunteers
- 230 people
- Sponsor
- Terumo Europe N.V.
Ischemic Stroke
Treatment With Intent to Generate Endovascular Reperfusion
Tigertriever is a CE marked mechanical revascularization device indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset.
- Trial name
- TIGER (NCT03474549)
- Testing
- Tigertriever revascularization device
- Where
- 17 sites in United States, Israel
- Volunteers
- 160 people
- Sponsor
- Rapid Medical
Aneurysm, Dissection, Aortic
Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis
The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular…
- Conditions
- Aneurysm, Dissection, Aortic, TAA Thoracoabdominal Aortic Aneurysm, Thoracic Aortic Aneurysm
- Trial name
- NCT06507865
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis
- Where
- 19 sites in Austria, Denmark and 7 more
- Volunteers
- 155 people
- Sponsor
- W.L.Gore & Associates
Cardiovascular Disease
X-ray Dose Reduction Study for Endovascular Interventional Radiology
ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly.
- Trial name
- NCT01599741
- Testing
- Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology., Normal dose DSA with conventional X-ray imaging technology
- Where
- Netherlands
- Volunteers
- 51 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Bleeding
Clinical Trial of the WC360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular Procedures
This Clinical Study is a pivotal study to evaluate the safety of the SiteSeal™ Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.
- Trial name
- SiteSeal (NCT03234894)
- Testing
- SiteSeal Endovascular
- Volunteers
- 90 people
- Sponsor
- Wound Care 360, Inc.
Aortic Aneurysm, Thoracic
VALIANT CAPTIVIA Post-market Registry
The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System (Captivia). This new delivery system was CE marked on September 14th, 2009 and was commercially released in the European Union on October…
- Trial name
- VCOUS (NCT01181947)
- Testing
- TEVAR
- Where
- 15 sites in Austria, Germany and 5 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiovascular
Artery Disease
Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries
The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of…
- Trial name
- NCT05902923
- Testing
- endovascular intervention
- Where
- 6 sites in France
- Volunteers
- 209 people
- Sponsor
- iVascular S.L.U.
Endovascular
Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure Device
To evaluate the safety and effectiveness of MynxGrip, in hemostasis of common femoral artery puncture site, compared with manual compression hemostasis in patients who have undergone diagnostic or interventional endovascular…
- Trial name
- PANDA (NCT03923387)
- Testing
- MynxGrip, Manual compression
- Where
- China
- Volunteers
- 306 people
- Sponsor
- Cordis US Corp.