Clinical trials: PERIPHERAL VASCULAR DISEASE
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.
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, Peripheral Vascular Diseases
BOLT Lithotripsy RESTORE ATK Trial
The RESTORE (ATK) above the knee study is a prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy System.
- Trial name
- RESTORE ATK (NCT05662787)
- Testing
- Intravascular Lithotripsy
- Where
- 11 sites in Austria, Croatia and 1 more
- Volunteers
- 97 people
- Sponsor
- Bolt Medical
Hematological Malignancies
Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer
The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the…
- Trial name
- NCT01607892
- Testing
- KPT-330
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 286 people
- Sponsor
- Karyopharm Therapeutics Inc
Peripheral Vascular Occlusive Disease
SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study
This is an open label, prospective, non-randomised, multi-centre post market study of the POUNCE Venous Thrombectomy system for de-clotting in the peripheral vasculature (e.g., iliofemoral veins).
- Trial name
- CHOMP (NCT05600816)
- Testing
- Pounce Venous Thrombectomy System
- Volunteers
- 40 people
- Sponsor
- SurModics, Inc.
Critical Limb Ischemia
An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)
This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a patient-specific expanded multicellular therapy, for the treatment of patients with critical limb ischemia (CLI).
- Trial name
- REVIVE (NCT01483898)
- Testing
- Ixmyelocel-T
- Where
- 86 sites in United States
- Volunteers
- 41 people
- Sponsor
- Vericel Corporation
Peripheral Arterial Disease, Intermittent Claudication
Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)
The purpose of this study is to determine whether 12 weeks of daily home use of the FM220 in the most affected leg of patients with PAD and claudication, will improve peak walking time (PWT) at three months as compared with a…
- Trial name
- NCT00146666
- Testing
- Intermittent compression
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- FlowMedic
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities
SELUTION4BTK Trial
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in…
- Trial name
- NCT05055297
- Testing
- SELUTION SLR™ DEB 014, Plain (Uncoated) Balloon Angioplasty (PTA)
- Where
- 48 sites in United States, Austria and 8 more
- Volunteers
- 376 people
- Sponsor
- M.A. Med Alliance S.A.
Intracranial Aneurysms, Peripheral Aneurysms
Study of the Penumbra Coil 400 System to Treat Aneurysm
This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System.
- Trial name
- ACE (NCT01465841)
- Testing
- PC 400 coils (Penumbra )
- Where
- 6 sites in United States
- Volunteers
- 517 people
- Sponsor
- Penumbra Inc.
Peripheral Arterial Disease
XPAD European Feasibility Study
A prospective, single arm, non-randomized European feasibility study to evaluate the safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective…
- Trial name
- NCT07716020
- Testing
- XPAD conduit
- Volunteers
- 15 people
- Sponsor
- Xeltis
Diabetes, Peripheral Arterial Disease
DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease
This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 for the improvement of ankle-brachial index in diabetic patients with peripheral arterial disease (PAD).
- Trial name
- NCT02145988
- Testing
- DLBS1033
- Where
- 2 sites in Indonesia
- Volunteers
- 11 people
- Sponsor
- Dexa Medica Group
Peripheral Arterial Disease, Peripheral Vascular Diseases
ACHIEVE GRX Registry
This study will evaluate real-world performance of the CorPath GRX System in peripheral vascular interventions.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Renal Artery Disease, Carotid Artery Diseases
- Trial name
- NCT04513613
- Testing
- Procedure/Surgery: Robotic-PVI
- Sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
Peripheral Arterial Disease (PAD)
Zilver Flex Post-Market Study in Japan
Japanese post market clinical study of the Zilver Flex device.
- Trial name
- NCT02254356
- Testing
- Zilver Flex Bare Metal Stent
- Where
- Japan
- Volunteers
- 239 people
- Sponsor
- Cook Group Incorporated
Peripheral Arterial Occlusion or Emboli
Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or…
- Trial name
- PRISM (NCT02085551)
- Testing
- Mechanical Thrombectomy by the Indigo System
- Where
- 5 sites in United States
- Volunteers
- 85 people
- Sponsor
- Penumbra Inc.
Peripheral Artery Disease, Femoropopliteal Artery Stenosis
Data Registry Following Patients Using Supera Stent in the Femoral Arteries
Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or…
- Conditions
- Peripheral Artery Disease, Femoropopliteal Artery Stenosis, Peripheral Vascular Disease
- Trial name
- STRONG (NCT01154751)
- Testing
- SUPERA Interwoven self-expanding nitinol stent
- Where
- 4 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Diabetic Foot, Diabetic Peripheral Neuropathy
Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy
The primary aim of this study is to use the Orpyx® SI Sensory Insole System (Orpyx Medical Technologies Inc., Calgary AB, Canada) ("Orpyx" or "the Company") as an adjunct to diabetic peripheral neuropathy standard of care (SOC)…
- Trial name
- NCT05613556
- Testing
- Orpyx SI® Sensory Insole System
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Orpyx Medical Technologies Inc.
Peripheral Arterial Disease
Remedy, Biodegradable Peripheral Stent Registry
This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries.
- Trial name
- NCT01420120
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- be Medical
Pathologic Processes, Diabetes Mellitus
Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs
The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers…
- Conditions
- Pathologic Processes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases
- Trial name
- C5CAMP (NCT06674980)
- Testing
- Standard of Care - DFU, AM/Single - DFU, AM/Double - DFU
- Where
- United States
- Volunteers
- 177 people
- Sponsor
- C5 Biomedical
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
SELUTION4SFA Trial
This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA)…
- Trial name
- NCT05132361
- Testing
- SELUTION SLR™ 018 DEB, Plain (Uncoated) Balloon Angioplasty (PTA)
- Where
- 38 sites in United States, Austria and 2 more
- Volunteers
- 300 people
- Sponsor
- M.A. Med Alliance S.A.
Peripheral Arterial Disease
BIO REsponse Adapted Combination Therapy Pilot Study
Both drug-coated balloon and stents have been used for a number of years to treat subjects with Peripheral Artery Disease (PAD) and are recognized as very good treatment methods.
- Trial name
- NCT03547986
- Testing
- Duplex Ultrasound (DUS), IVUS with Intraarterial pressure measurement (IAP) if needed
- Where
- 15 sites in Australia, Austria and 4 more
- Volunteers
- 150 people
- Sponsor
- Biotronik AG