The study is designed to prospectively collect data on and confirm the safety and effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and time to ambulation for patients who have undergone diagnostic or interventional catheterization procedures using up to 6F sheaths when compared with standard compression techniques using data from literature surveys.
Who can participate
Age range18 Years
SexALL
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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 diagnostic or interventional cardiac catheterization via a femoral sheath ≤6F.
* Age ≥18 years.
* Understand and sign the study specific written informed consent form.
* In the investigator's opinion, the patient is suitable for the X-Seal vascular closure device, conventional hemostasis techniques and participation in an investigational trial.
* Eligible for sheath removal in the catheterization lab.
Exclusion Criteria:
* Patients who are known to be pregnant or lactating.
* Patients who are immunocompromised.
* Prior target artery closure with any vascular closure device or closure with manual compression win 30 days prior to this procedure.
* Patients with significant anemia (hemoglobin \<10 g/DL, Hct\<30).
* Patients who are morbidly obese or cachectic (BMI \>40 or \<20 kg/m2).
* 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 drug or device that has not concluded the follow-up period.
* Patients with a baseline INR \> 1.5 (e.g. coumadin therapy).
* Patients with a known bleeding disorder including thrombocytopenia (platelet count \<100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand's disease.
* Patients with small femoral arteries (\<4 mm), femoral artery stenosis resulting in a vessel diameter \<4 mm, or patients with severe periphe…
What they're measuring
1
Major Complications
Timeframe: 30 days
2
Time-to-Hemostasis
Timeframe: Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding, assessed up to 2 hours.