Clinical trials: Aortic Aneurysms
Abdominal Aortic Aneurysms (AAA)
A Clinical Investigational Study of Ankura™ II AAA, IE and AE Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysm
The objective of this clinical investigational study is to evaluate the safety and efficacy of the Ankura™ II AAA, AE Stent Graft System and the large-size Ankura™ II IE Stent Graft System (i.e., IE stent grafts with distal…
- Trial name
- NCT07754240
- Testing
- Ankura™ II Abdominal Aortic Stent Graft System
- Where
- Bulgaria
- Volunteers
- 45 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
TAAA, AAA - Abdominal Aortic Aneurysm
Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)
The study aims to check whether the TUVA BX and iCover stent grafts are safe and work well when used during a specific type of minimally invasive surgery (BEVAR) to treat complex aortic aneurysms.
- Trial name
- NCT07540507
- Testing
- Endovascular Aortic Repair
- Where
- Netherlands
- Volunteers
- 105 people
- Sponsor
- JOTEC GmbH
Aortic Aneurysm, Aortic Aneurysm Abdominal
Evaluation of the iCover Stent as a Bridging Stent in Fenestrated Endovascular Aneurysm Repair (fEVAR) for Complex Aortic Aneurysms.
ReiCo is a French retrospective, multicenter, single-arm study focused on assessing the safety and clinical performance of the iCover balloon-expandable covered stent (iVascular) when implanted as a bridging stent during fEVAR…
- Trial name
- ReiCo (NCT07742254)
- Where
- 3 sites in France
- Volunteers
- 154 people
- Sponsor
- iVascular S.L.U.
Dissection of Aorta, Aneurysm Aortic
Retrospective Real-World Data Collection of the Conformable GORE® TAG® Thoracic Endoprosthesis When Used in Frozen Elephant Trunk Procedures for Treatment of Aortic Aneurysms and Dissections
Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen…
- Conditions
- Dissection of Aorta, Aneurysm Aortic, Frozen Elephant Trunk
- Trial name
- NCT07742592
- Testing
- Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
- Volunteers
- 350 people
- Sponsor
- W.L.Gore & Associates
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
Aortic Aneurysm, Aortic Aneurysm and Dissection
A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta
The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm and Dissection, Aortic Diseases, Aneurysm of Aorta, Thoracic
- Trial name
- RAPID (NCT07078383)
- Testing
- Rapidlink
- Where
- 21 sites in United States, Austria and 3 more
- Volunteers
- 150 people
- Sponsor
- Vascutek Ltd.
Aortic Aneurysm, Abdominal
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR)…
- Trial name
- NCT06029660
- Testing
- IMPEDE-FX RapidFill Implants, EndoVascular Aneurysm Repair
- Where
- 49 sites in United States, France and 3 more
- Volunteers
- 180 people
- Sponsor
- Shape Memory Medical, Inc.
Aneurysm of Aorta, Thoracic, Dissection of Aorta, Thoracic
TBE Zone 0/1 PMS in Japan
The goal of this surveillance is to confirm the safety and efficacy of TBE under actual use in the Zone 0/1 lesion on post-marketing usage conditions.
- Conditions
- Aneurysm of Aorta, Thoracic, Dissection of Aorta, Thoracic, Trauma
- Trial name
- NCT07691931
- Testing
- Gore® TAG® Thoracic Aortic Branch Stent Graft System
- Volunteers
- 75 people
- Sponsor
- W.L.Gore & Associates
Abdominal Aortic Aneurysm, Pararenal Aortic Aneurysm
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
This study aims to confirm that the benefit-risk assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy of the TAMBE Device training…
- Conditions
- Abdominal Aortic Aneurysm, Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
- Trial name
- NCT06578741
- Testing
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)
- Where
- United States
- Volunteers
- 310 people
- Sponsor
- W.L.Gore & Associates
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)
Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal…
- Conditions
- Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder), Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)
- Trial name
- ADVANCE (NCT05378347)
- Testing
- Medtronic Endurant II or Endurant IIs Stent Graft System, Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis
- Where
- 68 sites in United States, Finland and 10 more
- Volunteers
- 600 people
- Sponsor
- Medtronic Cardiovascular
Juxtarenal Abdominal Aortic Aneurysm
Safety and Efficacy Study of WeFlow-JAAA Stent Graft System for Complex Abdominal Aortic Aneurysm(GREAT Study)
A prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of WeFlow-JAAA stent graft system manufactured by Hangzhou Endonom Medtech Co., Ltd.
- Trial name
- NCT05179967
- Testing
- WeFlow-JAAA Stent Graft System
- Where
- China
- Volunteers
- 106 people
- Sponsor
- Hangzhou Endonom Medtech Co., Ltd.
Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent Graft
Post-market European & Asian Registry to Evaluate the Minos™ Stent-Graft and Delivery System in Abdominal Aortic Aneurysm Treatment
The Minos™ Abdominal Aortic Stent-Graft and Delivery System is a medical device designed to treat abdominal aortic aneurysms using a minimally invasive procedure.
- Trial name
- PEARL (NCT07674173)
- Testing
- Implantation with Minos Stent graft
- Where
- 16 sites in China, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Dissection of Thoracic Aorta, Dissection of Thoracic Descending Aorta
European Multi-Centre Post-Market Registry on Thoracic Endovascular Arch Repair Using Castor™ and Cratos™
The Castor™ and Cratos™ Branched Aortic Stent Graft Systems are medical devices designed for the minimally invasive endovascular treatment of thoracic aortic pathologies in the descending aorta.
- Conditions
- Dissection of Thoracic Aorta, Dissection of Thoracic Descending Aorta, Aneurysm of Aorta, Thoracic, Penetrating Aortic Ulcers (PAUs)
- Trial name
- CEDAR (NCT07668687)
- Testing
- Implantation with Castor™ stent graft, Implantation with Cratos™ stent graft
- Where
- 4 sites in Germany, Switzerland
- Volunteers
- 100 people
- Sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Abdominal Aortic Aneurysm
Nellix Registry Study: EVAS-Global
Multicenter, single arm, open label, registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System.
- Trial name
- EVAS FORWARD 2 (NCT02996396)
- Testing
- Nellix Endovascular Aneurysm Sealing System (Nellix®-System)
- Where
- 10 sites in Germany, Netherlands and 2 more
- Volunteers
- 48 people
- Sponsor
- Endologix
Aortic Aneurysm
Radiation Free Study
This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable.
- Trial name
- RadFree (NCT06549348)
- Testing
- Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance
- Where
- 11 sites in United States, Belgium and 4 more
- Volunteers
- 182 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
European Aortic Data Collection Project
The purpose of this study is to evaluate the safety and performance of Cook's various Custom-Made Stent-graft Devices (CMD) used for endovascular treatment of the aorta and related diseases by collecting information on the…
- Conditions
- Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm, Chronic Aortic Dissection
- Trial name
- EADC (NCT05896397)
- Testing
- Endovascular Aortic Treatments
- Where
- 18 sites in Denmark, France and 4 more
- Volunteers
- 600 people
- Sponsor
- Cook Research Incorporated
AAA - Abdominal Aortic Aneurysm
Endurant CHevAr New Indication Trial: ENCHANT
The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for…
- Trial name
- ENCHANT (NCT03320252)
- Testing
- Endurant Chimney Graft Technique
- Where
- 26 sites in Austria, France and 11 more
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Abdominal Aortic Aneurysm, Morbid Obesity
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
The aim of the study is to describe the effectiveness of Optilene® Silver Mesh Elastic on prevention of surgical site infection (SSI) at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on…
- Trial name
- SSIHLVER (NCT06547138)
- Testing
- Prophylactic mesh
- Where
- 5 sites in Spain
- Volunteers
- 110 people
- Sponsor
- Aesculap AG
Aortic Aneurysm, Thoracic, Pseudoaneurysm
Evaluation of the GORE® Ascending Stent Graft
The primary objective of ARISE II is to assess the safety and effectiveness of the GORE® Ascending Stent Graft device in the treatment of lesions involving the ascending aorta and aortic arch.
- Conditions
- Aortic Aneurysm, Thoracic, Pseudoaneurysm, Aortic Dissection, Aorta; Lesion
- Trial name
- ARISEII (NCT05800743)
- Testing
- GORE® Ascending Stent Graft (ASG device), GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device), Surgery
- Where
- 41 sites in United States
- Volunteers
- 370 people
- Sponsor
- W.L.Gore & Associates
Aneurysm Thoracic, Dissection of Thoracic Aorta
Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study
The purpose of this study is to collect clinical data on patient outcomes, evaluate the safety and performance of Ankura TAA Stent Graft System and Surpass Super Stiff Guidewire, and build clinical evidence for patients with…
- Trial name
- NCT05639569
- Testing
- Ankura™ TAA Stent Graft System
- Where
- 15 sites in Germany, Greece and 3 more
- Volunteers
- 147 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.