Clinical trials: Critical Ischemia
Cardiogenic Shock
The Current Status and Clinical OUTcomes of Cardiogenic Shock Patients And the Role of Specialist in Cardiovascular Critical Care Unit
In the case of cardiogenic shock, the early mortality rate is the highest compared to other types of shock, but it is characterized by a good prognosis and quality of life after recovery, so monitoring the treatment progress is…
- Trial name
- SCOUT SPARC (NCT05415332)
- Where
- South Korea
- Volunteers
- 10,000 people
- Sponsor
- Yonsei University
Peripheral Arterial Disease
ILLUMENATE Below-The-Knee (BTK) Arteries: a Post Market Clinical Study
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the StellarexTM 0.014" OTW Drug-coated Angioplasty Balloon in the treatment of lesions in "below the…
- Trial name
- BTK PMS (NCT03395236)
- Testing
- StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon
- Where
- 10 sites in Germany, Netherlands and 1 more
- Volunteers
- 49 people
- Sponsor
- Spectranetics Corporation
Critical Limb Ischemia
Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia
Percutaneous transluminal angioplasty (PTA) of infra-popliteal arteries in patients suffering peripheral arterial occlusive disease (PAOD) provides good results in terms of limb salvage.
- Trial name
- NCT02498080
- Testing
- DEB PTA, Standard PTA
- Volunteers
- 60 people
- Sponsor
- Neuromed IRCCS
Critical Limb Ischemia
Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study
Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb loss that is caused by severe compromise of blood flow to the affected extremity.
- Trial name
- STT-CLIPS (NCT02091921)
- Testing
- Ticagrelor
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Critical Limb Ischemia
SCOPE CLI (Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia)
Given the importance of understanding CLI patients' outcomes and existing gaps in knowledge, there is a pressing need to collect observational data on treatment patterns, adherence to performance measures, and outcomes that are…
- Trial name
- SCOPE CLI (NCT03171259)
- Testing
- care as usual
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Saint Luke's Health System
Critical Limb Ischemia
Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia
Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia.
- Trial name
- AGILITY (NCT02144610)
- Testing
- HGF Plasmid (AMG0001)
- Where
- 60 sites in United States, Belgium and 9 more
- Volunteers
- 46 people
- Sponsor
- AnGes USA, Inc.
Vascular Diseases
Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex
Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.
- Trial name
- NCT05296031
- Testing
- Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions, Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions
- Volunteers
- 49 people
- Sponsor
- Skane University Hospital
Vascular Diseases, Diabetes
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part II) (DCLI-II)
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-II (NCT01173094)
- Testing
- Percutaneous Transluminal Angioplasty, below-knee arterial bypass
- Where
- 3 sites in China
- Volunteers
- 130 people
- Sponsor
- Peking Union Medical College Hospital
Critical Limb Ischemia, Peripheral Arterial Disease
Pilot Safety Study of Injectable SIS for Critical Limb Ischemia
This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- CLIC (NCT02145845)
- Testing
- Injectable SIS
- Where
- Czechia
- Volunteers
- 13 people
- Sponsor
- Cook Group Incorporated
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.
Femoropopliteal Disease, Drug Coated Balloon
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
The aim of this clinical trial is to determine whether vessel preparation with a non-compliant scoring balloon before drug-coated balloon (DCB) angioplasty provides superior procedural and clinical outcomes compared with vessel…
- Conditions
- Femoropopliteal Disease, Drug Coated Balloon, Critical Limb-Threatening Ischaemia, Peripheral Arterial Disease
- Trial name
- DASBAD-NC (NCT07764016)
- Testing
- Non-compliant Plain Balloon angioplasty (PBA), Non-compliant Scoring Balloon Angioplasty (SB)
- Volunteers
- 142 people
- Sponsor
- Marc Sirvent
Venous Allogeneic Transplant, Occlusive Peripheral Arterial Disease
Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C (ERAV)
The main objective of this study is to assess the 2-year survival with salvage of the lower limb of patients who have undergone subgonal bypass grafting by venous allograft in the treatment of Occlusive Peripheral Arterial…
- Trial name
- ERAV (NCT05101512)
- Testing
- Questionnaires on quality of life after surgery
- Where
- France
- Volunteers
- 150 people
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
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.
Shock, Cardiogenic, Shock Hypovolemic
Clinical Validation of Algorithms for Mean Systemic Filling Pressure and Automated Cardiac Output
Prospective combined clinical validation of an algorithmic calculated mean systemic filling pressure (Pms-Nav) with the gold standard for Pms (Pms calculated from venous return curves during inspiratory hold procedures with…
- Conditions
- Shock, Cardiogenic, Shock Hypovolemic, Hypovolemia, Cardiac Failure
- Trial name
- PP3D (NCT04202432)
- Testing
- Mean systemic filling pressure
- Where
- Netherlands
- Volunteers
- 18 people
- Sponsor
- Catharina Ziekenhuis Eindhoven
Critical Limb Ischemia
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.
- Trial name
- ILLUMENATE-BTK (NCT03175744)
- Testing
- Stellarex DCB, PTA Catheter
- Where
- 21 sites in United States, Australia and 3 more
- Volunteers
- 82 people
- Sponsor
- Spectranetics Corporation
Critical Limb Ischemia
Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT
Using gene therapy to express active telomerase (hTERT) in human cells has the potential to treat many diseases related to aging, including critical limb ischemia (CLI).
- Trial name
- NCT04110964
- Testing
- AAV-hTERT
- Where
- Colombia
- Volunteers
- 5 people
- Sponsor
- Libella Gene Therapeutics
Critical Limb Ischemia (CLI)
IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease
A prospective, multi-center, randomized trial to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or…
- Trial name
- GENIUS (NCT04849325)
- Testing
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™), Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 29 sites in China
- Volunteers
- 120 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Critical Limb Ischemia, Ischemic Ulcers
Stem Cells for Treating Critical Ischemia
Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots
- Trial name
- NCT00488020
- Testing
- stem cells transplant
- Where
- Brazil
- Volunteers
- 10 people
- Sponsor
- Instituto de Molestias Cardiovasculares
Critical Limb Ischemia
Investigating the Safety and Efficacy of the Treatment With the Selution Sirolimus Coated Balloon in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia From Singapore
The objective of this clinical investigation is to evaluate the 6-month outcome of the Selution Sirolimus-coated Balloon for the treatment of long tibial occlusive disease (TASC C and D) in patients with Critical Limb Ischemia…
- Trial name
- PRESTIGE (NCT04071782)
- Testing
- Drug Coated Balloon
- Where
- Singapore
- Volunteers
- 25 people
- Sponsor
- Singapore General Hospital
Arterial Occlusive Diseases
Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD)
Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized…
- Trial name
- NCT00282646
- Testing
- intraarterial stem cell therapy, Stem cells
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Johann Wolfgang Goethe University Hospital