Please select the eligibility criteria that correspond to the clinical trial below.
Title: ECLIPSE Trial - Ensure's Vascular Closure Device Speeds Hemostasis Trial
Brief Summary: The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device is more effective than standard manual compression at sealing the puncture made in the femoral artery following a cardiac or peripheral diagnostic or interventional procedure while maintaining the same level of safety.


Options:
A: Inclusion Criteria:

* Male or female at least 18 years old
* Informed consent form understood and signed and patient agrees to all follow-up visits
* Abdominal aortic aneurysm (AAA) with maximum diameter ≥5cm, or in the range of 4 to 5cm which has increased by 0.5cm or more in the past six months
* Have a suitable ipsilateral common femoral artery for percutaneous access using a 'Pre-close' technique as detailed in the protocol
* Anatomically eligible for the IntuiTrak System per the FDA-approved indications for use (IFU)

Exclusion Criteria:

* Life expectancy \<1 year as judged by the investigator;
* Psychiatric or other condition that may interfere with the study;
* Participating in the enrollment or 30-day follow-up phase of another clinical study;
* Known allergy to any device component;
* Coagulopathy or uncontrolled bleeding disorder;
* Ruptured, leaking, or mycotic aneurysm;
* Serum creatinine (S-Cr) level \>1.7 mg/dL;
* Traumatic vascular injury;
* Active systemic or localized groin infection;
* Connective tissue disease (e.g., Marfan's Syndrome);
* Renal transplant patient;
* Recent (within prior three months) cerebrovascular accident or myocardial infarction;
* Planned major intervention or surgery within 30 days following the EVAR procedure;
* Requirement for an arterial conduit at the access site;
* Morbidly obese (BMI≥40);
* Calcification throughout the common femoral artery (CFA) target area anterior wall or circumferentially or over \>50% of the posterior wall;
* Femoral artery aneurysm, arteriovenous fistula or pseudoaneurysm;
* Evidence of prior common femoral artery surgery (e.g., groin incision);
* Prior clip-based vascular closure device placement in either arterial access site;
* Collagen-based vascular closure device placement in either arterial access site within the prior 90 days;
* Femoral artery needle puncture in either arterial access site within the prior 30 days;
* Hematoma at the ipsilateral arterial access site
* Significant scarring at the ipsilateral arterial access site
B: Inclusion Criteria:

* Scheduled for a coronary or peripheral diagnostic or interventional procedure
* Able to undergo emergent vascular surgery if a complication requires it
* 6F 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/m\^2
* 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. Coronary Artery Bypass Graft (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
C: Inclusion Criteria:

* Patient between 18 and 85 years of age
* Patients undergoing femoral access coronary angiography
* Access only with 6 F sheath
* Patient must be competent for providing informed written consent

Exclusion Criteria:

* Peripheral arterial occlusive disease
* Prior peripheral artery surgery
* Percutaneous coronary intervention
* Femoral access device closure in last 30 days
* Scheduled Coronary Angiography/Intervention within 90 days
* Critical limb ischemic
* Uncontrolled hypertension \>220/110 mmHg
* Coagulopathy (bleeding disorder)
* Local infection
* Common femoral artery lumen diameter \< 5 mm
* Allergy to absorbable suture
* Autoimmune Disease
* Pregnancy
D: Inclusion Criteria:

* The patient must be at least 18 years old
* Patients undergoing femoral access coronary angiography
* Patient must be competent for providing informed, written consent
* Only 6F sheath

Exclusion Criteria:

* Percutaneous coronary intervention
* Intra coronary measurements (FFR, IVUS, OCT, NIR)
* Groin hematoma before closure
* Pseudoaneurysm or AV fistula
* Significant stenosis of ilial or femoral artery
* Prior peripheral artery surgery
* INR \> 3,0
* Platelet count \< 120 million per millilitre blood
* Coagulopathy (bleeding disorder)
* Thrombolysis in the last 24h
* Planned heparin infusion after the procedure
* Pregnancy
* Uncontrolled hypertension \> 200 mmHg / 110 mmHg
* Femoral access device closure in the last 30 days

Answer: B