Clinical trials: Ischemia Limb
Peripheral Artery Disease, Critical Limb Ischemia
Complete Lesion Assessment With ffR and IVUS TechnologY
CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
- Trial name
- CLARITY I (NCT01941030)
- Testing
- Orbital Atherectomy System, Balloon Angioplasty
- Where
- 8 sites in United States
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Cardiac Surgery, Ischemia Limb
Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach
This is a first-in-human, prospective, single-arm, phase I clinical study evaluating the safety of the iPerf femoral arterial cannula in patients undergoing planned cardiac surgery requiring extracorporeal circulation (ECC) via a…
- Trial name
- FIH IPERF-01 (NCT07163234)
- Testing
- Cardiac surgery
- Where
- 2 sites in France
- Volunteers
- 15 people
- Sponsor
- IPERF SAS
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
Stroke, Stroke, Acute
Associative Peripheral Stimulation for Reduction of Motor Impairment During Acute Period of Stroke Recovery
Associative Peripheral Stimulation (APS) is a non-invasive therapy intended for stroke rehabilitation involving transcutaneous electrical muscle stimulation paired with voluntary movement.
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic, Stroke, Hemorrhagic
- Trial name
- APS-PILOT (NCT06575140)
- Testing
- Associative Peripheral Stimulation (APS) 1.0, Peripheral Neuromuscular Stimulation
- Where
- 3 sites in Mexico
- Volunteers
- 20 people
- Sponsor
- Ahmed A. Rahim
Vascular Diseases, Diabetes
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I)
The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts.
- Trial name
- DCLI-I (NCT01171703)
- Testing
- femoral-popliteal bypass, stent
- Where
- 3 sites in China
- Volunteers
- 70 people
- Sponsor
- Peking Union Medical College Hospital
Sarcopenia, Peripheral Arterial Disease
Sarcopenia and Peripheral Artery Disease With Chronic Limb Threatening Ischemia
To evaluate the correlation of Sarcopenia Parameters and Peripheral Artery Disease with chronic limb threatening ischaemia.
- Conditions
- Sarcopenia, Peripheral Arterial Disease, Chronic Limb Threatening Ischemia
- Trial name
- SAC (NCT07037979)
- Testing
- Not applicable- observational study
- Where
- China
- Volunteers
- 97 people
- Sponsor
- Fudan University
Peripheral Arterial Occlusive Disease, Bypass Complication
The SIR-POBA Bypass Trial
The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an infrainguinal venous bypass stenosis.
- Conditions
- Peripheral Arterial Occlusive Disease, Bypass Complication, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis
- Trial name
- NCT06056193
- Testing
- Balloon Angioplasty
- Where
- Austria
- Sponsor
- Paracelsus Medical University
Acute Ischemia of Lower Limb
The Indigo System in Acute Lower Limb Malperfusion
To evaluate, in a controlled setting, the early safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (San Francisco, California), and to define optimal technique for the use of these systems in patients…
- Trial name
- INDIAN (NCT03386370)
- Testing
- "Indigo" Mechanical Thrombectomy System
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Azienda Ospedaliera Universitaria Senese
Motor Impairment, Motor Impairments
Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Stroke
This study will evaluate the effects of transcutaneous vagus nerve stimulation in combination with physical rehabilitation on upper limb motor function of patients with stroke.
- Conditions
- Motor Impairment, Motor Impairments, Stroke, Stroke; Sequelae
- Trial name
- INPULSE (NCT06895005)
- Testing
- Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy
- Where
- Colombia
- Volunteers
- 30 people
- Sponsor
- Fundación Cardiovascular de Colombia
Peripheral Vascular Disease
Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft
Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia…
- Trial name
- NCT00067041
- Testing
- Remodulin (treprostinil sodium) Injection
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- United Therapeutics
Chronic Limb-threatening Ischemia, Microtia
the Gut Microbiome and Metabolomics in Chronic Lower extreMities Threatening Ischemia
Intestinal floras and their metabolites are involved in progressing metabolic and cardiovascular diseases. However, currently, articles related to the relationship between intestinal floras and atherosclerosis mainly focus on…
- Trial name
- MMM (NCT06220994)
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Beijing Tsinghua Chang Gung Hospital
Clinical Practice Guidelines, Lower Limb Amputation Above Knee (Injury)
TeleEducation for Implementing a Clinical Practice Guideline For Amputees
The publication of a Clinical Practice Guideline (CPG) is often not enough for its correct use in the field of health care. There are barriers to the implementation of the CPG recommendations, including those related to the lack…
- Conditions
- Clinical Practice Guidelines, Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Knee
- Trial name
- TEFICA (NCT05601349)
- Testing
- Telehealth-based strategy
- Where
- Colombia
- Volunteers
- 7 people
- Sponsor
- Grupo Rehabilitacion en Salud
Peripheral Arterial Disease, Critical Lower Limb Ischemia
Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon
To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.
- Trial name
- SWING (NCT04107298)
- Testing
- SUNDANCE™ Drug Coated Balloon
- Where
- 8 sites in Australia, Austria and 3 more
- Volunteers
- 35 people
- Sponsor
- SurModics, Inc.
Critical Limb Ischemia (CLI), Diabetes
Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients
A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose. The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs…
- Trial name
- NCT01257776
- Testing
- Autologous adipose derived mesenchymal stem cells
- Where
- 2 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Peripheral Arterial Disease Below the Knee, Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization
Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters
Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters ("BTK Multicath Registry") A non-randomized clinical registry This study is designed to obtain preliminary data on clinically…
- Trial name
- NCT06906055
- Testing
- Multicath, Standard of Care (SOC)
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Summa Therapeutics, LLC
Stroke
Evaluation of Diagnostic Criteria for Chronic Critical Limb Ischemia
Chronic critical limb ischemia (CCI) is the most severe clinical form of occlusive arterial disease. Its prognosis is terrible, mortality estimated at 50% in five years.
- Trial name
- CRIMI (NCT02834143)
- Testing
- No intervention
- Where
- France
- Volunteers
- 180 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Thrombolysis
CaveoVasc Thrombolysis Protection System, Access Protection Study
The CaveoVasc Thrombolysis Protection System is intended to aid sheath access and reduce bleeding complications during catheter directed thrombolysis (CDT) in the treatment of limb ischemia.
- Trial name
- NCT03166059
- Testing
- CaveoVasc® Thrombolysis Protection System
- Volunteers
- 20 people
- Sponsor
- CaveoMed GmbH
Peripheral Arterial Disease
Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent to Treat BTK Arteries
The objective of this clinical study is to evaluate the immediate and long-term (up to 12 month) safety and effectiveness of a Nitinol Self-Expanding Paclitaxel-Eluting stent for the treatment of patients with critical limb…
- Trial name
- PES-BTK-70 (NCT01630070)
- Testing
- Self-expandable drug eluting stent
- Where
- 5 sites in Belgium
- Volunteers
- 70 people
- Sponsor
- Flanders Medical Research Program
Obliterating Arteriopathy of the Lower Limbs
Protection of Arteritic Patients by Remote Preconditioning
Prospective, monocentric, randomised, double-blind study with 20 patients enrolled to be explored twice through a Cross-over strategy to determine whether remote preconditioning improves arteritic patients' ability to walk.
- Trial name
- PARADIS (NCT01971879)
- Testing
- Remote ischemic preconditioning, Control
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Angers
Critical Limb Ischemia
Safety Study of Gene Therapy in Treating Critical Leg Ischemia
The purpose of this study is to determine the safety, tolerability and preliminary efficacy of intramuscular injections of VM202 for subjects with critical limb ischemia.
- Trial name
- NCT00696124
- Testing
- VM202 2 mg, VM202 4 mg, VM202 8 mg
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Helixmith Co., Ltd.