Stenosis Clinical Trial
Official title:
BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis Trial
This study aims to assess the device success and the safety of Medinol's Drug Eluting Stent -
BioNIR - with a modified delivery system. The BioNIR Ridaforolimus Eluting Coronary Stent
System is a single use device/drug combination product comprising:
- A mounted Cobalt Chromium (CoCr) alloy based stent
- A Rapid Exchange (RX) delivery system
- A polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil®
- Ridaforolimus drug - CAS Registry Number: 572924-54-0 It is indicated for improving
coronary luminal diameter in patients with symptomatic heart disease due to lesions in
vessels with reference diameters of 2.5 mm to 4.25 mm, including complex lesions.
This is a prospective, multi-center, single arm, open label, clinical trial. Lesions planned
to be treated must be declared and recorded at time of enrollment. Planned staged procedures,
if necessary, must be declared immediately post procedure. Clinical follow-up will be
performed at 30 days.
Telephone follow-ups will be performed at 6 months and 1 year post procedure.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
| Recruiting |
NCT04584632 -
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
|
N/A | |
| Recruiting |
NCT02395354 -
Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease
|
N/A | |
| Withdrawn |
NCT00543348 -
RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
|
N/A | |
| Completed |
NCT00555659 -
Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusions
|
N/A | |
| Completed |
NCT00205101 -
Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
|
||
| Terminated |
NCT04370041 -
Dokimos Plus Aortic Valve Implant in 80 Patients Diagnosed With a Heart Valve Disease and Requiring Valve Replacement
|
N/A | |
| Recruiting |
NCT05053932 -
Long-term Comparative Cerebrovascular Outcome After Transplantation vs Standard Care in Sickle Cell Anemia
|
||
| Completed |
NCT02373852 -
PMS Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention
|
||
| Completed |
NCT01970579 -
Clinical Trial on Peripheral Arteries Treated With SeQuent® Please P Paclitaxel Coated Balloon Catheter
|
Phase 3 | |
| Completed |
NCT01873586 -
OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
|
N/A | |
| Completed |
NCT00540813 -
Paclitaxel-Eluting Balloon Angioplasty and Coroflex™-Stents in the Treatment of Bifurcated Coronary Lesions
|
N/A | |
| Recruiting |
NCT00496639 -
Stent vs. Angioplasty for Treatment of Thrombosed AV Grafts: Long-Term Outcomes
|
N/A | |
| Terminated |
NCT00254852 -
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
|
N/A | |
| Enrolling by invitation |
NCT05583305 -
Prevalence and Etiologies of Intracranial Stenosis in Patients With Antiphospholipid Syndrome
|
||
| Completed |
NCT02018445 -
Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion
|
N/A | |
| Withdrawn |
NCT03327272 -
Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
|
Phase 3 | |
| Completed |
NCT04698512 -
MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial
|
||
| Active, not recruiting |
NCT02428582 -
Covered Stents Versus Bare-Metal Stents
|
N/A | |
| Completed |
NCT01742117 -
Tailored Antiplatelet Therapy Following PCI
|
Phase 4 |