Clinical trials: Chronic Limb-threatening Ischemia
Chronic Limb Threatening Ischaemia
Duplex UltraSound afTer Endo Revascularisation - Feasibility Randomised Control Trial (DUSTER)
17, 000 people every year in the UK develop foot pain or wounds from blocked leg arteries. If left untreated, this can lead to amputation.
- Trial name
- DUSTER (NCT06702306)
- Testing
- Ultrasound Surveillance
- Where
- United Kingdom
- Volunteers
- 70 people
- Sponsor
- Mid and South Essex NHS Foundation Trust
Peripheral Arterial Disease
HORIZON Prospective Clinical Investigation
The objective of this clinical investigation is to demonstrate and provide long term clinical data on safety and performance of the Exist 6F NiTi stent system type FLEX \& PULL in a prospective investigation for the treatment of…
- Trial name
- NCT05234164
- Testing
- EXIST 6F NiTi Stent System FLEX, EXIST 6F NiTi Stent System PULL
- Where
- 2 sites in Italy, Poland
- Volunteers
- 69 people
- Sponsor
- Qmedics AG
End Stage Renal Disease
Effect of Hemodialysis on Toe Pressure- and Finger Pressure and Skin Autofluorescence in Hemodialysis Patients
The aim of this study is to determine the vascular condition of hemodialysis patients with toe pressure measurement, finger pressure measurement and measuring glycated and oxidated proteins by skin autofluorescence.
- Trial name
- NCT00431314
- Volunteers
- 82 people
- Sponsor
- Isala
Critical Limb Ischemia
A Safety and Efficacy Study of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia
This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in critical limb ischemia.
- Trial name
- NCT02477540
- Testing
- Cellgram-CLI
- Sponsor
- Pharmicell Co., Ltd.
Critical Limb Ischemia
Revascularization in Nonagenarian Patients With Critical Lower Limb Ischaemia
The rise in life expectancy implies an increased number of nonagenarian patients who need evaluation for critical lower limb ischaemia (CLI).
- Trial name
- NONA-CLI (NCT02517840)
- Volunteers
- 53 people
- Sponsor
- Hospital Universitario Getafe
Angioplasty, Anaesthesia and Analgesia
Popliteal Block for Lower Limb Angioplasty
Endovascular revascularization is an effective procedure in treatment of chronic critical limb ischemia. The less invasive procedure in high risk patients produce the benefit to the patients.
- Trial name
- NCT04445480
- Testing
- Popliteal block, Control
- Where
- Thailand
- Volunteers
- 40 people
- Sponsor
- Mahidol University
Chronic Limb Threatening Ischemia, Infrapopliteal Arterial Occlusive Disease
Revascularization of Single Vesrus Multiple Infrapopliteal Vessels in Chronic Limb Threatening Ischemia
This interventional prospective study aims to assess the effectiveness of single vessel versus multiple vessel infrapopliteal angioplasty in patients with chronic threatening limb ischemia .
- Trial name
- NCT07068789
- Testing
- balloon angioplasty
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Sohag University
Peripheral Arterial Disease, Aortoiliac Occlusive Disease
Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study
Peripheral arterial disease involving the iliac arteries is a common manifestation of systemic atherosclerosis and a major cause of lifestyle-limiting claudication and chronic limb-threatening ischemia.
- Conditions
- Peripheral Arterial Disease, Aortoiliac Occlusive Disease, Chronic Limb-Threatening Ischemia, Intermittent Claudication
- Trial name
- PREMISE-ILIAC (NCT07672249)
- Testing
- Iliac stenting
- Where
- Italy
- Volunteers
- 98 people
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Critical Lower Limb Ischemia, Postoperative Complications
Impact of Nutritional and Inflammatory Status in Patients With Critical Limb-threatening Ischemia
The peripheral arterial disease (PAD) has been associated with all-cause and cardiovascular mortality. Despite minimally invasive endovascular techniques, patients with critical limb-threatening ischemia (CLTI) have a poor…
- Trial name
- NCT04756115
- Testing
- Vascular Surgery.
- Where
- Spain
- Volunteers
- 310 people
- Sponsor
- Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Critical Limb Ischemia (CLI), Popliteal Nerve Block
Ultrasound-Guided Sciatic Popliteal Nerve Block vs. Erector Spinae Plane Block in Endovascular Management of CLI
Comparison of popliteal sciatic nerve block and erector spinae plane block (ESPB) in patients undergoing endovascular management of critical lower limb ischemia (CLI).
- Conditions
- Critical Limb Ischemia (CLI), Popliteal Nerve Block, ESPB
- Trial name
- NCT06913348
- Testing
- Popliteal sciatic nerve block
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Minia University Hospital
Peripheral Artery Disease
Cardiovascular Biomarkers in Peripheral Artery Disease.
Despite the best medical management, many patients with peripheral artery disease (PAD) who undergo lower extremity endovascular revascularization experience adverse cardiovascular outcomes and postoperative complications that…
- Trial name
- NCT05757258
- Where
- Italy
- Volunteers
- 207 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive…
- Trial name
- NCT03124875
- Testing
- LimFlow System
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- LimFlow, Inc.
Peripheral Arterial Occlusive Disease, Critical Limb Ischemia
Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC in Subjects With PAOD/CLI and Healthy Volunteers (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET/CT = Positron Emission Tomography/Computed Tomography)
The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of [89Zr]Zr-DFO-APAC in patients with peripheral arterial occlusive disease / critical limb ischemia (PAOD/CLI) and healthy volunteers.
- Trial name
- CHASE (NCT06204237)
- Testing
- [89Zr]Zr-DFO-APAC, PET/CT scan
- Where
- Netherlands
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Aplagon Oy
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
Critical Limb Ischemia
Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization
Peripheral Arterial Occlusive Disease is associated with a high risk of cardiovascular events. The critical ischemia stage represents the most severe stage of Peripheral Arterial Occlusive Disease, associated with decubitus pain…
- Trial name
- CLI ENDOVASC (NCT04312451)
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Peripheral Arterial Disease(PAD), Chronic Limb Threatening Ischemia
Intravascular Ultrasound for Peripheral Artery Disease Revascularization
The purpose of this study is to determine if IVUS use, as compared to angiography alone, prevent major adverse limb events (MALE) or binary restenosis (a greater than 50% re-narrowing of the treated artery) in adult patients who…
- Conditions
- Peripheral Arterial Disease(PAD), Chronic Limb Threatening Ischemia, Intravascular Ultrasound, Major Adverse Limb Events
- Trial name
- CLARITY (NCT06979284)
- Testing
- IVUS-guided strategy
- Where
- 5 sites in Canada
- Volunteers
- 772 people
- Sponsor
- Hamilton Health Sciences Corporation
Peripheral Arterial Occlusive Disease
Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
The study is to confirmatorily show a superior effect of Alprostadil compared to placebo on the rate of complete healing of ischemic necroses and ulcerations as well as on the frequency and height of major amputations in patients…
- Trial name
- ESPECIAL (NCT00596752)
- Testing
- Alprostadil
- Where
- 78 sites in Czechia, Germany and 4 more
- Volunteers
- 840 people
- Sponsor
- UCB BIOSCIENCES GmbH
Critical Limb Ischemia
PROMISE International
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
- NCT03321552
- Testing
- Percutaneous deep vein arterialization, LimFlow System
- Where
- 12 sites in Austria, Germany and 3 more
- Volunteers
- 34 people
- Sponsor
- LimFlow SA
Peripheral Vascular Disease
PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia
The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb…
- Trial name
- PADI (NCT00471289)
- Testing
- PTA with placement of paclitaxel-eluting stent, PTA
- Where
- 3 sites in Netherlands
- Volunteers
- 144 people
- Sponsor
- Netherlands Society for Interventional Radiology
Chronic Threatening Lower Limb Ischemia
Duplex Ultrasound Versus Conventional Angiography in Evaluating Lower Limb Threatening Ischemia
This study aims to evaluate the accuracy of Duplex Ultrasound (DUS) in assessing infra inguinal arterial lesions in patients with chronic threatening limb ischemia compared with digital subtraction angiography (DSA) as the…
- Trial name
- DUS-CTA (NCT07113197)
- Testing
- conventional angiography
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Sohag University