Peripheral Vascular Diseases Clinical Trial
Official title:
A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy and Safety of XRP0038/NV1FGF on Amputation or Any Death in Critical Limb Ischemia Patients With Skin Lesions
Primary objective is to demonstrate the superiority of riferminogene pecaplasmid over
placebo in the prevention of major amputation above the ankle of the treated leg or of death
from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin
lesions.
Secondary objectives are to evaluate:
- The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major
amputation;
- The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to
death;
- The safety of riferminogene pecaplasmid in the study population.
The study consists in 6-week treatment then a follow-up period up to 12 months. A follow-up
contact is then scheduled 6 months later.
Per protocol amendment a 18-month long-term safety survey was added.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
| Completed |
NCT00536796 -
Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets
|
N/A | |
| Completed |
NCT00371371 -
Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT00173602 -
The Burden of Peripheral Artery Occlusion Disease and Associated Factors in Peritoneal Dialysis Patients
|
N/A | |
| Completed |
NCT00163267 -
Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel
|
Phase 2/Phase 3 | |
| Completed |
NCT00228384 -
GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
|
Phase 4 | |
| Completed |
NCT00106327 -
Improving Functioning in Peripheral Arterial Disease
|
N/A | |
| Completed |
NCT00049907 -
Cardiac and Renal Disease Study (CARDS)
|
N/A | |
| Completed |
NCT00000614 -
Prevention of Recurrent Venous Thromboembolism (PREVENT)
|
Phase 3 | |
| Completed |
NCT00005392 -
Epidemiology of Venous Disease
|
N/A | |
| Recruiting |
NCT05596760 -
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers
|
N/A | |
| Recruiting |
NCT00539266 -
Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia
|
Phase 2/Phase 3 | |
| Completed |
NCT00520312 -
Magnetic Resonance Imaging to Identify Characteristics of Plaque Build-Up in People With Peripheral Arterial Disease
|
N/A | |
| Completed |
NCT00541307 -
GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)
|
N/A | |
| Terminated |
NCT00504088 -
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
|
Phase 4 | |
| Completed |
NCT00533104 -
Cell Therapy in Chronic Limb Ischemia
|
Phase 1/Phase 2 | |
| Enrolling by invitation |
NCT05459818 -
Individual Patient Data Analysis of Viabahn for Peripheral Arterial Disease
|
||
| Completed |
NCT03875846 -
Intraoperative Simultaneous Pressure Guided Revascularization Study
|
||
| Active, not recruiting |
NCT05110677 -
Pilot Study of Topographic Imaging of the Calf Muscle in Patients With PAD Using 3D Reconstruction of MSOT Images
|
||
| Active, not recruiting |
NCT02856230 -
An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)
|
Phase 2/Phase 3 |