Skip to main content
MedPathMedPath Home
Clinical Trials/NL-OMON55148
NL-OMON55148
Withdrawn
Not Applicable

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Performance of the Leaflex* Performer - The Leaflex* Standalone Study

Pi-Cardia Ltd.0 sites10 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Pi-Cardia Ltd.
Enrollment
10
Status
Withdrawn
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Male and female age \>18 years.
  • •2\. Patient with severe aortic stenosis.
  • •3\. Senile degenerative severe aortic valve stenosis with echocardiography
  • •derived criteria: mean gradient \> 40 mmHg OR jet velocity \> 4\.0 m/s OR AVA \*
  • •1\.0 cm2 OR AVA index (AVAi) \* 0\.6 cm2/m2\.
  • •4\. NYHA Functional Class \* 2 OR exercise test that demonstrates a limited
  • •exercise capacity, abnormal BP response, or arrhythmia.
  • •5\. Not recommended by the heart team for immediate treatment with surgical or
  • •transcatheter aortic valve replacement.

Exclusion Criteria

  • •1\. Aortic valve is unicuspid, bicuspid, or non\-calcified.
  • •2\. Severe aortic regurgitation (\>2\+).
  • •3\. An exceptional aortic valve leaflet Calcium morphology, as determined by the
  • •CT Core Lab.
  • •4\. Pre\-existing mechanical or bioprosthetic aortic or mitral valve.
  • •5\. Iliofemoral vessel characteristics that would preclude safe placement of the
  • •introducer sheath.
  • •6\. Coronary disease that, in the opinion of the heart team, should be treated;
  • •or treatment of coronary disease \* 1 month prior to index procedure.
  • •7\. Aortic balloon valvuloplasty \* 3 months prior to index procedure.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
A Prospective, Multi-Center, Non-Randomized, Single-Arm Study of the BARD® LIFESTREAM™ Balloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease (BOLSTER)I70.2Atherosclerosis of arteries of extremities
DRKS00006828Bard Peripheral Vascular, Inc.154
Completed
Phase 2
A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross* Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions.PCI CTOstenosis1001108210003216
NL-OMON41722itiloop Ltd.50
Completed
Not Applicable
A NON-RANDOMIZED, MULTI-CENTER, PROSPECTIVE, SINGLE ARM CLINICAL STUDY OF THE X-SUIT NIR® COVERED BILIARY METALLIC STENT FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE VIA ENDOSCOPIC APPROACH
NL-OMON41690Medinol Ltd15
Completed
Not Applicable
Prospective, multicenter, non-randomized, single-arm observational study to evaluate safety and effectiveness of iCover covered stent for the treatment of the aorto-iliac Occlusive DiseaseAorto-Iliacal Artheropathy
DRKS00028124IVascular240
Not yet recruiting
Not Applicable
First in Human Early Feasibility study of BD(TM) Sirolimus Drug Coated Balloon Catheter for Treatment of Femoropopliteal Arteries
ACTRN12622000071729Becton, Dickinson and Company (BD)50