Clinical trials: Critical Ischemia Limb
Peripheral Vascular Disease, Intermittent Claudication
DURABILITY-200: EverFlex 200mm Long Nitinol Stents in TASC C&D Femoropopliteal Lesions
The objective of this clinical investigation is to evaluate the long-term (up to 12 months) outcome of the 200 mm long self-expanding nitinol EverFlex (ev3) stent in long femoropopliteal lesions (TASC C \& D) Is is the first time…
- Conditions
- Peripheral Vascular Disease, Intermittent Claudication, Critical Limb Ischemia
- Trial name
- NCT00637741
- Testing
- Everflex 200
- Where
- 2 sites in Belgium
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Flanders Medical Research Program
Peripheral Artery Disease, Critical Limb Ischemia
Platelet Reactivity in PAD Undergoing Percutaneous Angioplasty
Dual antiplatelet therapy has a key role in a prevention of thrombosis of treated artery in patients undergoing percutaneous transluminal angioplasty (PTA).
- Conditions
- Peripheral Artery Disease, Critical Limb Ischemia, Claudication, Intermittent
- Trial name
- PAD (NCT04165629)
- Testing
- Aspirin 300mg and Clopidogrel 300mg
- Where
- Serbia
- Volunteers
- 450 people
- Sponsor
- Clinical Centre of Serbia
Peripheral Vascular Disease, Intermittent Claudication
Intermittent Negative Pressure; Impact on Peripheral Artery Disease and Intermittent Claudication
The objective is to ensure the pro-active collection of information on quality, safety and performance of FlowOx™ after it is placed on the market.
- Conditions
- Peripheral Vascular Disease, Intermittent Claudication, Walking, Difficulty, Critical Limb Ischemia
- Trial name
- FlowOx (NCT04100681)
- Testing
- Active FlowOx™
- Where
- 5 sites in Germany
- Volunteers
- 16 people
- Sponsor
- Otivio AS
Peripheral Artery Disease, Quality of Life
VADOplex Critical Limb Ischemia Study
In patients with critical limb ischemia (CLI) and foot ulcers wound healing is an important goal which can normally only be achieved after sufficient treatment of the underlying ischemia (revascularization either by an operation…
- Conditions
- Peripheral Artery Disease, Quality of Life, Wound Healing
- Trial name
- NCT02034539
- Testing
- VADOplex system
- Where
- Germany
- Volunteers
- 38 people
- Sponsor
- Asklepios Kliniken Hamburg GmbH
Cardiovascular Diseases, Peripheral Vascular Disease
The COPPER-B Trial
The purpose of the COPPER - B study is to assess the feasibility, safety, and initial efficacy of paclitaxel administration using the OPC for the prevention of restenosis in infrapopliteal de novo and restenotic lesions and…
- Conditions
- Cardiovascular Diseases, Peripheral Vascular Disease, Arterial Occlusive Diseases, Peripheral Arterial Disease
- Trial name
- COPPER-B (NCT02395744)
- Testing
- Paclitaxel administration using the OPC
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- Horizons International Peripheral Group
Chronic Limb-Threatening Ischemia
AcoArt Litos PCB Below-the-knee Global Trial
The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of…
- Trial name
- NCT06330493
- Testing
- PCB, PTA
- Where
- 18 sites in United States, Austria and 1 more
- Volunteers
- 75 people
- Sponsor
- Acotec Scientific Co., Ltd
Compartment Syndrome of Leg, Extracorporeal Membrane Oxygenation Complication
Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients
Acute compartment syndrome (ACS) is a surgical emergency that can develop in patients on extracorporeal membrane oxygenation (ECMO).
- Conditions
- Compartment Syndrome of Leg, Extracorporeal Membrane Oxygenation Complication, Limb Ischemia, Limb Ischemia, Critical
- Trial name
- VA-ECMO (NCT05830721)
- Testing
- MY01 + Standard of Care, 14-Gauge Slit Catheter + Standard of Care, Standard of Care
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Johns Hopkins University
Critical Limb Ischemia
Prospective Observation Study of Outcome of Interventions for Critical Ischemia
Severe atherosclerosis in the leg arteries is termed critical limb ischemia (CLI). This condition gives great suffering for the patients in terms of pain, wounds and often developing gangrene.
- Trial name
- PROVENCE (NCT01794494)
- Testing
- Bypass surgery, Endovascular recanalization
- Where
- Sweden
- Volunteers
- 190 people
- Sponsor
- Sahlgrenska University Hospital
Peripheral Arterial Disease
Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia
This is a single center, prospective, randomized, unblinded, open-label, active controlled pilot study to evaluate the efficacy and safety of ticagrelor plus aspirin versus clopidogrel plus aspirin in patients with Rutherford…
- Trial name
- NCT02230527
- Testing
- Ticagrelor, Clopidogrel
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- The Cleveland Clinic
Critical Limb Ischemia (CLI)
Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI)
This is an Expanded Access program (EAP), sponsored by WideTrial for the treatment of critical limb ischemia (CLI). Widetrial, an Expanded Access specialist, has arranged to supply participating sites with PLX-PAD for CLI…
- Trial name
- NCT03746899
- Testing
- PLX-PAD
- Sponsor
- WideTrial, Inc.
Peripheral Artery Disease
Utility of Sortilin as a Biomarker of Restenosis After Lower Extremity Endovascular Revascularization
Sortilin is a 95-kDa protein related to circulating cholesterol. It is found inside different cell types and circulating in blood and it has been associated with the risk of atherosclerosis development and cardiovascular…
- Trial name
- NCT05759130
- Where
- Italy
- Volunteers
- 207 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Diabetes, Critical Limb Ischemia
Diabetic Foot and Vascular Progenitor Cells
Type of Study: Pilot Study monocenter Study Duration: 18 months Subject Participation Duration: The patients are enrolled for the time of the blood withdrawl. Follow up visit will be after 12 months from the enrollement.
- Trial name
- NCT01269580
- Where
- Italy
- Volunteers
- 122 people
- Sponsor
- IRCCS Multimedica
Critical Limb Ischaemia, Claudication
Peripheral Vascular Disease and Nerve Stimulation
A study to see what effect the geko™ device has on blood flow in patients with lower limb vascular disease.
- Conditions
- Critical Limb Ischaemia, Claudication, Ulcers, Varicose Veins
- Trial name
- CCLINS (NCT01942941)
- Testing
- geko™ electrical stimulation
- Where
- United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hull University Teaching Hospitals NHS Trust
Stenosis, Occlusion
Local Paclitaxel or Balloon Angioplasty Below the Knee
Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries
- Conditions
- Stenosis, Occlusion, Restenosis
- Trial name
- SAMBA (NCT03149913)
- Testing
- SequentPlease OTW paclitaxel coated balloon catheter, conventional uncoated balloon for BTK endovascular therapy
- Where
- 7 sites in Austria, Germany
- Volunteers
- 120 people
- Sponsor
- Prof. Dr. med. Gunnar Tepe
Peripheral Vascular Diseases, Peripheral Arterial Disease
Calf Muscle Perfusion in Patients With Intermittent Claudication by Non-invasive MSOT
The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the calf muscle based on multispectral optoacoustic tomography (MSOT) in a cross-sectional…
- Conditions
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Intermittent Claudication
- Trial name
- MSOT_IC (NCT05373927)
- Testing
- Multispectral Optoacoustic Tomography (MSOT)
- Where
- Germany
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Ulrich Rother
Type 2 Diabetes Mellitus, Diabetic Foot
Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia
Diabetic foot syndrome (DFS) is a disease caused by neurogenic (concerning the nervous system), vascular, mechanic and metabolic factors, which are further complicated by an impairment of the immune system and a corresponding…
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Foot, Critical Limb Ischemia
- Trial name
- August-1 (NCT01599442)
- Where
- Germany
- Volunteers
- 123 people
- Sponsor
- GWT-TUD GmbH
Critical Limb Ischemia (CLI)
Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
A Phase III study of PLX-PAD for CLI patients with minor tissue loss who are unsuitable for revascularization has been initiated (PLX-CLI-03, PACE study).
- Trial name
- NCT03886506
- Testing
- PLX-PAD
- Where
- 2 sites in United States
- Sponsor
- Pluristem Ltd.
Critical Limb Ischemia
Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
- Trial name
- NCT02046226
- Testing
- Oxygenesys(TM) Dissolved Oxygen Dressing
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Halyard Health
Critical Lower Limb Ischemia
Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia
The present randomized study proposed to compare the immediate postoperative and 2-year clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.
- Trial name
- NCT04490408
- Testing
- long surgical bypass, Hybrid approach
- Volunteers
- 52 people
- Sponsor
- Egyptian Biomedical Research Network
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.