Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT00533156
Eligibility Criteria:
Inclusion Criteria:
* Scheduled for a coronary diagnostic or interventional procedure
* Able to undergo emergent vascular surgery if a complication requires it
* 7F arterial puncture located in the common femoral artery
* Femoral artery has a lumen diameter of at least 5 mm
Exclusion Criteria:
* Arterial puncture in the femoral artery of both legs
* Prior target artery closure with any vascular closure device, or closure with manual compression within 30 days prior to catheterization
* Patients who bruise or bleed easily or with a history of significant bleeding or platelet disorders
* Acute ST-elevation myocardial infarction within 48 hours prior to catheterization
* Uncontrolled hypertension at time of vessel closure
* Elevated Activated Clotting Time at time of vessel closure
* Ineligible for in-catheterization lab introducer sheath removal
* Concurrent participation in another investigational device or drug trial
* Thrombolytic therapy, bivalirudin, other thrombin-specific anticoagulants, or low molecular weight heparin within 24 hours prior to catheterization
* Preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to femoral artery closure
* Prior femoral vascular surgery or vascular graft in region of access site
* Femoral artery is tortuous or requires an introducer sheath longer than 11 cm
* Fluoroscopically visible calcium, atherosclerotic disease, or stent within 1 cm of the puncture site that would interfere with the operation of the experimental device
* Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
* Antegrade vascular puncture
* Body Mass Index over 40 kg/m2
* Symptomatic leg ischemia in the target limb including severe claudication or weak/absent pulse
* Femoral artery diameter stenosis exceeding 50%
* Pre-existing severe non-cardiac systemic disease or terminal illness
* Planned arterial access at the same access site within 30 days of catheterization
* Extended hospitalization (e.g. CABG surgery)
* Pre-existing systemic or cutaneous infection
* Prior use of an intra-aortic balloon pump through the arterial access site
* Cardiogenic shock during or immediately following the catheterization
* Patient is unable to ambulate at baseline
* Patient is known or suspected to be pregnant or is lactating
* Patient is unavailable for follow-up
* Any angiographic or clinical evidence that the physician feels would place the patient at increased risk with the use of the experimental device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00533156
Study Brief:
Protocol Section:
NCT00533156