N/A
N=351
A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System
Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer
Bottom Line
View on ClinicalTrials.gov: NCT01271946 ↗Enrolled (actual)
351
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diagnostic catheterization procedure (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Arstasis, Inc.
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events. |
— | — |
| PRIMARY Major Adverse Events Reported as Percentage of Participants With Adverse Events. |
0; 0 | — |
| PRIMARY Device Success |
97; 100 | — |
| PRIMARY Minor Adverse Events |
4.0; 0 | — |
| PRIMARY Time to Hemostasis |
4.0 | — |
| PRIMARY Time to Discharge Eligibility |
6.0; 10.7 | — |
| PRIMARY Time to Actual Discharge |
9.3; 12.8 | — |
| PRIMARY Time to Ambulation |
1.5 | — |
| PRIMARY Percentage of Participants With Bed Elevation Within 15 Minutes. |
99.6; 20 | — |
| SECONDARY Time to Hemostasis |
4.0 | — |
| SECONDARY Time to Ambulation |
1.5 | — |
Summary
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT01271946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.