Ultrasound-guided Femoral Puncture to Reduce Access- Related Complications After TAVR: (ACCESS-TA… (NCT05637983) | Clinical Trial Compass
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Ultrasound-guided Femoral Puncture to Reduce Access- Related Complications After TAVR: (ACCESS-TAVR SIRIO)
Italy508 participantsStarted 2022-07-04
Plain-language summary
Recent observational data showed a marked reduction of vascular and bleeding complications by the use of ultrasound(US)-guided femoral artery puncture to gain the vascular access and guide the implantation of the Perclose ProGlide® vascular closure system.
We aimed to compare in a 1:1 randomized fashion the effect of US-guided femoral puncture and Perclose ProGlide® implantation optimization vs fluoroscopy-guided puncture followed by Perclose ProGlide/ ProStyle implantation (standard approach) during TAVR.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Eligible Patients are male or female with severe aortic stenosis evaluated by the Heart Team as candidate to TAVR based on the current cardiology guidelines.
Exclusion Criteria:
* Refusal to participate in the study;
* Inability to provide written consent to the study protocol;
* Chronic immuno-suppressant therapy;
* Any concomitant condition which, in the opinion of the Investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological disorder);
* Enrolment in another study that could confound the results of this study;
* Life expectancy \< 1 year;
* Any contraindication to TAVR procedure;
* Non transfemoral TAVR.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite of CV mortality, vascular complications or access-related bleeding after TAVR at 30 days.