Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device (NCT02521948) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
Italy, Netherlands50 participantsStarted 2015-07
Plain-language summary
The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of supporting a CE Mark (Conformite Europeenne--"European Conformity") and other regulatory submissions. The study will assess whether the MANTA VCD is safe and performs as intended for large-bore vascular closure after interventional procedures.
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:
* Candidate for non-emergent transcatheter interventional procedure via a 10-18F femoral sheath (e.g., transcatheter aortic valve replacement \[TAVR\], balloon aortic valvuloplasty \[BAV\], Abdominal Aortic Aneurysm \[AAA\] stent-graft placement)
* Eligible for sheath removal in the catheterization lab
* Age ≥18 years
* Understand and sign the study specific written informed consent form
* Able and willing to fulfill the follow-up requirements
* In the Investigator's opinion, the patient is suitable for the MANTA vascular closure device, conventional hemostasis techniques and participation in an investigational trial
* Patients of childbearing age with Negative Pregnancy Test within 7 days of procedure
Exclusion Criteria:
Baseline Exclusions:
* Patients who are known to be pregnant or lactating
* Patients who are immunocompromised or with pre-existing autoimmune disease
* Patients who have a systemic infection or a local infection at or near the access site
* Patients requiring a re-puncture at a site previously punctured within 48 hours
* Patients with significant anemia (hemoglobin \< 6.5 mmol/l, Hct\<30)
* Patients who are morbidly obese or cachectic (BMI \>40 or \<20)
* Patients with Systolic Blood Pressure \>180 mmHg, unless Systolic Pressure can be lowered by pharmacological agents prior to closure
* Patients who are currently participating in another clinical trial of an investigational device or drug that has not concluded the follow-up period
…
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
Number of Participants With Major Complications
Timeframe: Within either the first 30 days (plus or minus 7 days) after the procedure or the first 60 days (plus or minus 14 days) after the procedure
2
Hemostasis Success
Timeframe: Within the first 10 minutes of cutting the MANTA suture