Clinical trials: Endovascular Procedures
Vascular Anomalies, Hemorrhage
Safety and Efficacy Of Amber Peripheral Liquid Embolic System
A prospective, single-arm, multicenter, open-label, First-in-Human \& Pivotal Study to assess the safety and efficacy of amber SEL-P in 70 patients requiring peripheral embolization: vascular anomalies, hemorrhages, aneurysms…
- Conditions
- Vascular Anomalies, Hemorrhage, Aneurysm, Pseudoaneurysm
- Trial name
- OPAL (NCT06456125)
- Testing
- amber SEL-P Peripheral Liquid Embolic System
- Where
- Spain
- Volunteers
- 70 people
- Sponsor
- LVD Biotech S.L
Surgical Wound
RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)
The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites.
- Trial name
- RESPECT (NCT01297322)
- Testing
- Manual compression, Cardiva VASCADE™ Vascular Closure System
- Where
- 21 sites in United States, Australia
- Volunteers
- 420 people
- Sponsor
- Cardiva Medical, Inc.
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
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.
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.
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
Chronic Limb Ischemia, Non-Healing Ulcers
Hyperspectral Imaging Pre and Post Endovascular Intervention
This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.
- Trial name
- CLI-Pre/Post (NCT00768495)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- HyperMed
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
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.
Endovascular Procedures
Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events
To evaluate the safety and accuracy of the Saranas EBBMS for the detection of access site related internal bleeding events during large-bore endovascular procedures.
- Trial name
- NCT03621202
- Testing
- Saranas Early Bird Bleed Monitoring System (EBBMS)
- Where
- 5 sites in United States
- Volunteers
- 66 people
- Sponsor
- Saranas, Inc.
End Stage Kidney Disease, Chronic Kidney Diseases
The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation
This is a global, multi-center, prospective, post-market, confirmatory, interventional, non-randomized, single-arm clinical investigation evaluating arteriovenous fistula (AVF) creation by means of the WavelinQ™ EndoAVF System in…
- Conditions
- End Stage Kidney Disease, Chronic Kidney Diseases, Kidney Failure, Kidney Insufficiency
- Trial name
- WAVE-Global (NCT04626427)
- Testing
- WavelinQ™ EndoAVF System
- Where
- 3 sites in Belgium, Greece and 1 more
- Volunteers
- 21 people
- Sponsor
- C. R. Bard
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
Intracranial Aneurysms
Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques
To date the standard non-surgical treatment strategy for treating un-ruptured intracranial aneurysms is the use of either coils or self-expandable stents.
- Trial name
- NCT01084681
- Testing
- Endovascular treatment of intracranial aneurysms, Endovascular treatment of intracranial aneurysm with coils
- Where
- Germany
- Volunteers
- 160 people
- Sponsor
- Balt International
Percutaneous Intervention Via Femoral Artery
Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures
The purpose of this study is to evaluate the effectiveness and safety of the suture-mediated closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. following endovascular peripheral arterial procedures.
- Trial name
- NCT05899478
- Testing
- Tyknot® Suture-Mediated Closure System, Perclose® ProGlide Suture-Mediated Closure System
- Where
- 5 sites in China
- Volunteers
- 135 people
- Sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
Stroke
Clotild® Smart Guidewire System (CSGS) Evaluation in EndovascUlar Thrombectomy Procedure
The purpose of this First-in-Human study is to evaluate the safety of using the Clotild® system to guide the endovascular thrombectomy (EVT) device to the clot location during EVT for the treatment of an acute ischemic stroke…
- Trial name
- CLOTOUT (NCT04993079)
- Testing
- Clotild® Smart Guidewire System (CSGS)
- Where
- 3 sites in Australia, France
- Volunteers
- 45 people
- Sponsor
- Sensome
Peripheral Arterial Disease
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Lower Extremity Arteriosclerosis Occlusive Lumen
This trial was a prospective, multicenter, single-group design. To undergo endovascular treatment of lower extremity arteriosclerosis obliterans After the subjects were selected and enrolled, the surgeons used the endovascular…
- Trial name
- NCT05625711
- Testing
- The endovascular interventional surgical instrument control system
- Volunteers
- 260 people
- Sponsor
- Shanghai Operation Robot Co., Ltd.
Stroke, Intracranial Atherosclerotic Stenosis
SeQuent ® Please CIS for the Treatment of INtracranial Atherosclerotic Stenosis
This study is aiming to evaluate the safety and efficacy of SeQuent® Please CIS in the endovascular treatment of symptomatic intracranial atherosclerotic stenosis and restenosis after interventional therapy.
- Trial name
- SPINAS (NCT06047964)
- Testing
- DCB, POBA
- Where
- 9 sites in China
- Volunteers
- 281 people
- Sponsor
- B. Braun Medical International Trading Company Ltd.
Any Disease Which Requires Peripheral Endovascular Intervention
SENTANTE: Fully Robotic Peripheral Endovascular Interventions
The objective of the study is to evaluate the feasibility, safety and initial efficacy of the clinical and technical performance of the SENTANTE robotic system in the remote delivery and manipulation of commonly used and…
- Trial name
- ESSENTIAL (NCT06537947)
- Testing
- Endovascular intervention using the SENTANTE endovascular robotic system
- Where
- Latvia
- Volunteers
- 10 people
- Sponsor
- Inovatyvi Medicina UAB
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.
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.