Atherosclerosis Clinical Trial
Official title:
ABLUMINUS Below the Knee (BTK) Drug Eluting Stent (DES) Registry (ABLUMINUS BTK) - First in Men
A prospective, single center, single arm non-randomized trial collecting safety and effectiveness data for the ABLUMINUS DES System to treat BTK lesions in subjects with CLI.
The burden of limb loss as a result of peripheral arterial disease (PAD) is high and this problem is set to worsen globally with increasing prevalence of diabetes. Treatment of PAD in diabetic critical limb ischemia (CLI) primarily involves revascularisation of the limb. Angioplasty as a first line strategy of revascularization over surgical procedures has been adopted by most vascular centers. Arterial blockages for diabetic CLI patients occur predominantly in below the knee arteries which can be challenging to treat effectively. This is due to the high incidence of arterial recoil after conventional balloon angioplasty due the natural tendency of the vessels to maintain their original shape and the high restenosis rates of calcified lesions. To address these problems the novel ABLUMINUS DES system is specifically designed to withstand the mechanical recoil of diseased BTK arteries whilst delivering sirolimus to biologically inhibit restenosis. This study postulates that the application of the ABLUMINUS DES system will be safe and will result in better vascular patency in BTK arteries for CLI patients. The investigators aim to conduct a prospective, all comers, single arm, single centre registry of the ABLUMINUS DES system for the treatment of BTK disease. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05052918 -
The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
|
N/A | |
| Recruiting |
NCT04511234 -
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
|
N/A | |
| Completed |
NCT05906797 -
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.
|
N/A | |
| Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
| Suspended |
NCT02932176 -
Machine Learning for Handheld Vascular Studies
|
||
| Recruiting |
NCT05158257 -
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
|
N/A | |
| Completed |
NCT01212900 -
Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression
|
Phase 4 | |
| Completed |
NCT03697382 -
Effect of Daily Steps on Fat Metabolism
|
N/A | |
| Recruiting |
NCT06230406 -
T-Mem GEne in Atherosclerosis
|
||
| Completed |
NCT03654313 -
Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus
|
Phase 1 | |
| Completed |
NCT00382564 -
Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease
|
N/A | |
| Recruiting |
NCT02894931 -
Effects of Dietary Interventions on Serum and Macrophage Atherogenicity
|
N/A | |
| Completed |
NCT02998918 -
Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL
|
N/A | |
| Not yet recruiting |
NCT02578355 -
National Plaque Registry and Database
|
N/A | |
| Recruiting |
NCT02265250 -
Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
|
||
| Completed |
NCT03393377 -
Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination
|
N/A | |
| Completed |
NCT02268513 -
Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
|
||
| Completed |
NCT02224339 -
New Technologies to Determine Carotid Plaque Vulnerability
|
||
| Completed |
NCT02116829 -
Is There Room for Butter in a Healthy Diet?
|
N/A | |
| Completed |
NCT02377310 -
Pd/Pa vs iFR™ in an Unselected Population Referred for Invasive Angiography
|
N/A |