A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System (RECITAL)

Arstasis

Status

Completed

Conditions

Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer

Treatments

Device: Diagnostic catheterization procedure

Study type

Interventional

Funder types

Industry

Identifiers

NCT01271946

RC-03133

Details and patient eligibility

About

The goal of this study is to observe the clinical safety and effectiveness of the ArstasisOne Access System in patients undergoing diagnostic angiographic procedures through the femoral artery.

Enrollment

351 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is between 18 and 85 years of age.
Patient is clinically indicated for a diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.
Patient is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.

Exclusion criteria

Patient is unable to routinely walk at least 20 feet without assistance (e.g., requires a walker or wheelchair to mobilize or has known paralysis).
Patient has an active systemic or cutaneous infection or inflammation (e.g., septicemia at the time of the procedure).
Patient has systemic hypertension unresponsive to treatment (>180mmHg systolic and >110mmHg diastolic).
Patient has received thrombolytic therapy within the 72 hours prior to catheterization.
Patient has a previously diagnosed significant bleeding coagulopathy, is on warfarin and has an INR ≥ 1.5 or has a platelet disorder, including known thrombocytopenia (platelet count <100,000), thrombasthenia, Von Willebrand's disease, Factor V deficiency, or anemia (Hemoglobin< 10 g/dL, or Hct<30%).
Patient has a compromised femoral artery access site.
Patient procedure requires an introducer sheath size of> 6F.
Patient has had prior vascular surgery or vascular grafts at the femoral artery access site.
Patient presents with hemodynamic instability or is in need of emergent surgery.
Patient has received femoral artery closure on the target access vessel with a collagen/PEG closure device within 90 days of the current procedure.
Patient has a pre-existing severe non-cardiac systemic disease or illness that results in an expected life expectancy of< 30 dys or for other reasons has a life expectancy of less than 1 yaer.
Patient is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
Pregnant or lactating patients.