Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography: the CLOSE-UP I Randomized Trial
Brief Summary: Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?


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:

* 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
C: 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
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: D