Safety and Effectiveness of an Expandable/Retractable Introducer Sheath
Not Applicable
- Conditions
- Aortic stenosisCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemSurgery - Other surgery
- Registration Number
- ACTRN12623000479606
- Lead Sponsor
- Three Peaks Medical Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
1. Indicated for TAVR procedure incorporating a compatible device
Exclusion Criteria
1.Prior intervention/stenting in the aorta and/or ilio-femoral arteries
2.Severely calcified or highly tortuous peripheral vasculature
3.Medical, social, or psychological condition that in the opinion of an Investigator precludes the subject from appropriate consent
4.Concurrently participating in another cardiovascular device trial
5.Subject refuses a blood transfusion
6.Recent cerebrovascular accident or transient ischemic attack (within 90 days)
7.Recent emergency surgery for any reason (within 30 days)
8.Any percutaneous peripheral interventional procedure performed within 30 days prior to the procedure
9.Aged under 18 at time of consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method