Clinical trials: Stage II Peripheral Arterial Occlusive Disease
Critical Limb Ischemia (CLI)
Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Non-diabetic Patients With Critical Limb Ischemia (CLI).
Phase II Clinical Trial, a prospective, multicenter, open, randomized, parallel-group controlled with three levels of dose. The hypothesis of the test we propose is that the mononuclear cells of bone marrow provide progenitor…
- Trial name
- NCT01408381
- Testing
- Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells
- Where
- 5 sites in Spain
- Volunteers
- 38 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Peripheral Arterial Disease
Optimization of Treatment in Patients With Severe Peripheral Ischemia (Fontaine Stage IIb)
Evaluate the possibility of optimization of therapy with prostanoids (iloprost), in patients with Fontaine's stage IIb severe chronic ischemia, both in patients eligible for surgery both in patients for which it is only possible…
- Trial name
- 2bPILOT (NCT01718288)
- Testing
- iloprost, Standard Treatment (aspirin.....),
- Where
- 14 sites in Italy
- Volunteers
- 150 people
- Sponsor
- Fadoi Foundation, Italy
Peripheral Arterial Disease
Pilot Study of Vitamin D Screening Use in Peripheral Arterial Disease Patient Over Maximum Distance Walking
The prevalence of peripheral arterial disease (PAD) is greater than 15%. PAD is associated with an increased risk of cardiovascular death, coronary heart disease and stroke, with a mortality rate of 5% per year.
- Trial name
- First-BLINDOS (NCT03615833)
- Testing
- Cholecalciferol
- Where
- France
- Volunteers
- 27 people
- Sponsor
- University Hospital, Angers
Peripheral Vascular Diseases
Phase I/II Trial of Endometrial Regenerative Cells (ERC) in Patients With Critical Limb Ischemia
This is a 15 patient clinical trial assessing the safety and feasibility of using Endometrial Regenerative Cells (ERC) in patients with critical limb ischemia (CLI) that are not eligible for surgical or catheter-based…
- Trial name
- NCT01558908
- Testing
- Administration of ERC
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Medistem Inc.
Critical Limb Ischemia
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia.
- Trial name
- NCT01064440
- Testing
- Low Dose VM202, High Dose VM202
- Where
- 16 sites in United States, South Korea
- Volunteers
- 52 people
- Sponsor
- Helixmith Co., Ltd.
Peripheral Arterial Occlusive Disease, Critical Limb Ischemia
Autologous BMMNC Combined With HA Therapy for PAOD
The purpose of this study is to evaluate the safety and efficacy of hyaluronan combined with autologous bone marrow mononuclear cells for the treatment of critical PAOD patients.
- Trial name
- NCT03214887
- Testing
- RV-P1501
- Where
- 2 sites in Taiwan
- Sponsor
- Academia Sinica, Taiwan
Peripheral Vascular Disease
Prostaglandin E1 (Liprostin) Treatment With Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
This is the first clinical research trial in which intravenous Prostaglandin E1 (PGE1 is a vasoactive hormone) will be used as supportive treatment along with the angioplasty procedure to treat or open up a blocked artery within…
- Trial name
- NCT00053716
- Testing
- Liprostin [liposomal Prostaglandin E1]
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Endovasc
Arterial Occlusive Diseases
A Dose Escalation and Safety Study of Plasmin (Human) In Acute Lower Extremity Native Artery or Bypass Graft Occlusion
The purpose of this study is to evaluate the safety of increasing doses of intra-thrombus Plasmin (Human) in acute peripheral arterial occlusion (aPAO).
- Trial name
- PRIORITY (NCT00418483)
- Testing
- Plasmin (Human) 25 mg, Plasmin (Human) 50 mg, Plasmin (Human) 75 mg
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- Grifols Therapeutics LLC
Peripheral Vascular Disease
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amputation.
- Trial name
- NCT00300040
- Testing
- Hemoglobin glutamer 250 - bovine, 6% Hydroxyethylstarch
- Where
- 5 sites in South Africa, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Biopure Corporation
Peripheral Artery Disease (PAD)
Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR
To compare the effect of ticagrelor versus aspirin on the change in peak walking time, evaluated on the graded treadmill test, from one to 26 weeks post-revascularization in patients with peripheral artery disease who have…
- Trial name
- TI-PAD EVR (NCT02227368)
- Testing
- Ticagrelor, Comparator
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Peripheral Arterial Disease
Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease
This study is a double-blind study to evaluate the efficacy and safety of NV1FGF, a pCOR plasmid constructed by inserting the gene coding for the FGF compared to placebo in patients with severe Peripheral Arterial Occlusive…
- Trial name
- TALISMAN 201 (NCT00368797)
- Testing
- XRP0038 (NV1FGF)
- Where
- 6 sites in Belgium, France and 4 more
- Volunteers
- 125 people
- Sponsor
- Sanofi
Critical Limb Ischemia
Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients.
Clinical trial phase I / II, prospective, multicenter, open, randomized, parallel-groups controlled by two levels of dose to assess the safety and feasibility of the infusion of mesenchymal stem cells from adipose tissue…
- Trial name
- NCT01745744
- Testing
- Mesenchymal stem cells from adipose tissue
- Where
- 2 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Critical Limb Ischemia
To Evaluate the Safety and Efficacy of IM and IV Administration of Autologous ADMSCs for Treatment of CLI
Various preclinical animal studies have shown the potential of stem cells in re-vascularising ischemic limbs and promoting collateral vessel formation.
- Trial name
- NCT02145897
- Testing
- Autologous Stromal Vascular Fraction (SVF), Autologous Adipose Derieved MSCs, Control
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Kasiak Research Pvt. Ltd.
Peripheral Arterial Disease
Safety and Efficacy Study of a New Intermittent Pneumatic Compression Device to Treat Patients With Peripheral Arterial Disease (PAD) Stage II
The purpose of this study is to evaluate the safety and efficacy of new intermittent pneumatic compression device on initial claudication distance in patients with Peripheral Arterial Disease stage II
- Trial name
- NCT00762086
- Testing
- AngioPress Intermittent pneumatic compression (IPC) Device, Medications and Standard walking exercises
- Where
- 4 sites in Germany, Israel
- Volunteers
- 67 people
- Sponsor
- Mego Afek Ltd.
Peripheral Artery Disease
Alprostadil Liposomes for Injection for Lower Extremity Arteriosclerosis Obliteran
This is a randomized, positive-control, multicenter, multiple-dose, dose-escalation phase II trial
- Trial name
- NCT04197323
- Testing
- Alprostadil liposomes for injection
- Where
- China
- Volunteers
- 20 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Intermittent Claudication, Peripheral Artery Disease
Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)
The objective of the study is to establish the safety profile of Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects comprising of 4 treatment groups: 1.
- Trial name
- NCT01679990
- Testing
- PLX-PAD Low dose, PLX-PAD high doses
- Where
- 34 sites in United States, Germany and 2 more
- Volunteers
- 180 people
- Sponsor
- Pluristem Ltd.
Peripheral Arterial Disease, Leg Ulcer
Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia
Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI) of the affected lower limb, characterized by pain at rest, ulcerations or gangrene, with a high risk of amputation.
- Trial name
- NCT06326203
- Testing
- CELULAS TRONCO, CONVENTIONAL DRESSING
- Volunteers
- 40 people
- Sponsor
- UPECLIN HC FM Botucatu Unesp
Critical Limb Ischemia (CLI), Diabetic Foot
Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization
The aim of the study is to evaluate the safety and feasibility of autologous bone marrow mononuclear cells autologous administered intra-arterially in the affected limb of diabetic patients with chronic critical ischemia of the…
- Trial name
- NCT00987363
- Testing
- Intraarterial infusion of autologous bone marrow cells
- Where
- 5 sites in Spain
- Volunteers
- 60 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Peripheral Vascular Disease
Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
This is a phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with intermittent claudication (IC) will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg…
- Trial name
- NCT00113009
- Testing
- VLTS-934
- Where
- 32 sites in United States
- Volunteers
- 148 people
- Sponsor
- Valentis
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.