Clinical trials: Peripheral Artery Diseases
Peripheral Arterial Disease
Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD)
This trial is a First in Human early feasibility study of a novel atherectomy device to treat peripheral artery disease. The trial is a prospective, single arm design that will enroll 10 patients at 1 - 2 sites.
- Trial name
- FAST (NCT03365154)
- Testing
- Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment, Balloon Angioplasty
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Cardio Flow, Inc.
Peripheral Artery Disease
Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2
The purpose of this study is to monitor changes in local tissue oxygen levels in participants with Peripheral Artery Disease (PAD) using the Wireless Lumee Oxygen Platform.
- Trial name
- NCT04514861
- Testing
- Wireless Lumee Oxygen Platform
- Where
- 3 sites in United States
- Volunteers
- 53 people
- Sponsor
- Profusa, Inc.
Arterial Occlusive Diseases
Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
The purpose of the trial is to evaluate the safety and efficacy of microplasmin administration in patients with acute peripheral arterial occlusion.
- Trial name
- NCT00123292
- Testing
- Microplasmin
- Where
- Belgium
- Volunteers
- 19 people
- Sponsor
- ThromboGenics
Peripheral Arterial Disease, Chronic Limb Ischemia
Improving Radiological Outcomes in Arterial Disease - A Pilot Evaluation of the Pedra Tissue Perfusion Monitoring System
The Pedra Technologies' PedraTM device is a non-invasive, diagnostic device intended to measure foot perfusion by assessing blood flow.
- Trial name
- IROAD (NCT03294902)
- Testing
- Pedra Tissue Perfusion Monitor
- Where
- United Kingdom
- Volunteers
- 68 people
- Sponsor
- Pedra Technology, PTE LTD
Peripheral Arterial Disease
The Isthmus Logic Post Market Clinical Follow-up Study
Isthmus Logic Carbostent™ is a CE-marked cobalt chromium stent with a bio inducer surface for the treatment of peripheral iliac artery disease.
- Trial name
- NCT05616143
- Testing
- Isthmus Logic
- Where
- Italy
- Volunteers
- 37 people
- Sponsor
- CID S.p.A.
Lumbar Spinal Stenosis, Intermittent Claudication
Investigating Superion™ In Spinal Stenosis
The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of…
- Trial name
- NCT00692276
- Testing
- Superion™ Interspinous Spacer, X-STOP® IPD® Device
- Where
- 32 sites in United States
- Volunteers
- 391 people
- Sponsor
- Boston Scientific Corporation
Vascular Diseases, Peripheral Arterial Disease
Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery
The objective of this post-market clinical follow-up study is to evaluate the clinical outcomes of patients receiving PhotoFix as a patch within a vascular repair or reconstruction procedure.
- Conditions
- Vascular Diseases, Peripheral Arterial Disease, Hemodialysis Access Failure (Disorder), Carotid Artery Diseases
- Trial name
- PHOTO-V (NCT03669042)
- Testing
- PhotoFix
- Where
- 9 sites in United States
- Volunteers
- 94 people
- Sponsor
- Artivion Inc.
Peripheral Artery Disease
BRight DCB First-in-Human Study
The primary aim of this clinical study is to assess the safety and clinical performance of the BRight drug-coated balloon (DCB) in the treatment of lower limb arteries stenosis in subjects with Peripheral Artery Disease (PAD).
- Trial name
- NCT04525794
- Testing
- BRight DCB
- Where
- 7 sites in Australia, Austria and 2 more
- Volunteers
- 48 people
- Sponsor
- Biotronik CRC Inc.
Peripheral Artery Disease
Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal Arteries:
To describe the pharmacokinetics of paclitaxel in the blood delivered from a paclitaxel coated percutaneous angioplasty balloon catheter as a result of treatment of de novo or restenotic lesion(s), occluded/stenotic or…
- Trial name
- PK (NCT01912937)
- Testing
- Angioplasty treatment with the CVI Drug-coated Balloon (DCB)
- Where
- 2 sites in New Zealand
- Volunteers
- 25 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease
A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages
To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.
- Trial name
- NCT04241224
- Testing
- Atherectomy
- Where
- 10 sites in United States
- Volunteers
- 108 people
- Sponsor
- Ra Medical Systems
Peripheral Vascular Disease
Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial
This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease.
- Trial name
- ENDURE (NCT02129127)
- Testing
- Paclitaxel Coated Chocolate Balloon Angioplasty
- Where
- 2 sites in Germany, New Zealand
- Volunteers
- 67 people
- Sponsor
- TriReme Medical, LLC
Critical Limb Ischemia
Percutaneous Deep Vein Arterialization Post-Market Study
The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.
- Trial name
- PROMISE UK (NCT03807661)
- Testing
- Percutaneous deep vein arterialization, LimFlow System
- Where
- 6 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- LimFlow SA
Peripheral Arterial Occlusive Disease (PAOD)
Evaluation of FUSION™ Vascular Graft for Above Knee Targets
The purpose of the post-market study was to evaluate the safety and performance of the FUSION Vascular Graft.
- Trial name
- PERFECTION (NCT01601496)
- Testing
- FUSION Vascular Graft
- Where
- 10 sites in Austria, Germany
- Volunteers
- 117 people
- Sponsor
- Maquet Cardiovascular
Peripheral Artery Disease
IV-X Medical First-in-Human Peripheral Intravascular Lithotripsy Study for PAD
To evaluate the safety and performance of the IV-X Medical Intravascular Lithotripsy (IVL) System in adults in order to demonstrate the ability of the IV-X Medical IVL System to safely and effectively deliver IVL treatment…
- Trial name
- HELIX-PAD-FIH (NCT07747883)
- Testing
- IV-X Medical IVL System
- Where
- Paraguay
- Volunteers
- 25 people
- Sponsor
- IVX Medical
Peripheral Arterial Disease
FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter
The FORWARD PAD IDE Study is a prospective, multi-center, single-arm investigational device exemption study, conducted to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment…
- Trial name
- FORWARD PAD (NCT05858905)
- Testing
- Intravascular Lithotripsy
- Where
- 21 sites in United States
- Volunteers
- 75 people
- Sponsor
- Shockwave Medical, Inc.
Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
BGC101 (EnEPC) Autologous Cell Therapy From Patient's Own Blood for Treatment of Critical Limb Ischemia (CLI)
Evaluate the feasibility of an autologous cell preparation composed of a mixture of cells enriched for endothelial progenitor cells (EnEPCs) and multipotent adult hematopoietic stem/progenitor cells (HSPC) (BGC101), in the…
- Conditions
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- EnEPC-CLI (NCT02805023)
- Testing
- BGC101 (autologous EnEPC preparation), Control medium
- Where
- 5 sites in United States, Israel
- Volunteers
- 40 people
- Sponsor
- BioGenCell Ltd.
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
Peripheral Arterial Disease (PAD)
Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses
This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.
- Trial name
- XPEDITE (NCT02936622)
- Testing
- Zilver® Paclitaxel-Eluting Peripheral Stent, Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating, Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating
- Where
- 11 sites in Germany, New Zealand
- Volunteers
- 176 people
- Sponsor
- Cook Group Incorporated
ASCVD
The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)
cvMOBIUS is a North American registry of patients with ASCVD aimed at understanding patterns of care in ASCVD while evaluating the real world effectiveness of PCSK9 inhibitors.
- Trial name
- cvMOBIUS (NCT04197453)
- Where
- 164 sites in United States, Canada
- Volunteers
- 752 people
- Sponsor
- Amgen
Peripheral Vascular Disease
Zilver PTX Delivery System
The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.
- Trial name
- NCT02271529
- Testing
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Where
- 6 sites in Australia, Germany and 1 more
- Volunteers
- 40 people
- Sponsor
- Cook Group Incorporated