Clinical trials: Peripheral Endovascular Intervention
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.
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 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
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.
Coronary Artery Disease, Peripheral Arterial Disease
Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.
- Trial name
- NCT05747287
- Testing
- microcatheter
- Where
- 3 sites in China
- Volunteers
- 60 people
- Sponsor
- BrosMed Medical Co., Ltd
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
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.
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.
Peripheral Arterial Disease Below The Knee
Investigating the Safety and Clinical Performance of Seven iVascular Devices for Endovascular Intervention in the Popliteal and/or Infrapopliteal Arteries
The rationale of this study is to confirm and support the clinical safety and performance of the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated Balloons, the Angiolite BTK…
- Trial name
- POP-BTK (NCT05267548)
- Where
- 8 sites in Belgium
- Volunteers
- 143 people
- Sponsor
- iVascular S.L.U.
Peripheral Arterial Disease, Peripheral Artery Disease
Tissue Monitoring During Endovascular Intervention
Tissue perfusion assessment is key to more accurate measurement of foot ischemia, which is in turn an important factor in appropriate treatment decisions.
- Conditions
- Peripheral Arterial Disease, Peripheral Artery Disease, Arterial Occlusive Diseases
- Trial name
- TIME (NCT04744870)
- Volunteers
- 80 people
- Sponsor
- Pedra Technology, PTE LTD
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
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.
Peripheral Vascular Disease, Coronary Artery Disease
Angio-Seal Evolution Device Registry
Collect data on the use of the Angio-Seal Evolution Device in diagnostic and interventional patient populations.
- Conditions
- Peripheral Vascular Disease, Coronary Artery Disease, Peripheral Artery Disease, Arterial Occlusive Disease
- Trial name
- NCT00817349
- Where
- 10 sites in United States
- Volunteers
- 1,004 people
- Sponsor
- Abbott Medical Devices
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
Peripheral Arterial Disease
Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures
Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands…
- Trial name
- BIO-OSCAR SOC (NCT05831319)
- Where
- 17 sites in Austria, Belgium and 6 more
- Volunteers
- 380 people
- Sponsor
- Biotronik AG
Peripheral Artery Disease, Peripheral Vascular Disease
Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe
BIOFLEX-I EU is the European arm of the BIOFLEX-I IDE study (NCT01319812). Data from BIOFLEX-I EU will be pooled with data in the IDE.
- Trial name
- BIOFLEX-I EU (NCT01661231)
- Testing
- Astron/Pulsar-18 stent
- Where
- 7 sites in Austria, Belgium and 2 more
- Volunteers
- 456 people
- Sponsor
- Biotronik AG
Peripheral Vascular Interventions
Assessment of Clin. Capabilities of LIBERTY® Endovascular Robotic System's Performance & Safety in Periph. Vasc. Interv.
A prospective, multi-center, single-arm, study to evaluate the performance and safety of the LIBERTY® Robotic System in human subjects undergoing Peripheral Vascular Interventions.
- Trial name
- ACCESS-PVI (NCT06141694)
- Testing
- The LIBERTY® Robotic System
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Microbot Medical, INC
Vascular Closure, Endovascular Procedure
Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
The present post-market surveillance study aims to evaluate the safety and effectiveness of the Angio-SealTM VIP VCD in patients undergoing endovascular procedures via femoral access in real-world setting.
- Conditions
- Vascular Closure, Endovascular Procedure, Hemostasis, Peripheral Vascular Disease
- Trial name
- NCT05335525
- Testing
- Closure of the femoral arterial puncture site
- Where
- 4 sites in France, Germany and 1 more
- Volunteers
- 230 people
- Sponsor
- Terumo Europe N.V.
Peripheral Arterial Disease, Peripheral Artery Disease
Preliminary Tissue Monitoring During Endovascular Intervention Study
Tissue perfusion assessment is key to more accurate measurement of foot ischemia, which is in turn an important factor in appropriate treatment decisions.
- Conditions
- Peripheral Arterial Disease, Peripheral Artery Disease, Arterial Occlusive Diseases
- Trial name
- mini-TIME (NCT04956523)
- Volunteers
- 20 people
- Sponsor
- Pedra Technology, PTE LTD
Surgical Wound
VASCADE ANTEGRADE-PVD Post-Market Registry
The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional…
- Trial name
- NCT02948257
- Testing
- Cardiva Medical VASCADE VCS
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Cardiva Medical, Inc.