Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer
Conditions
Brief 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.
Interventions
DEVICEDiagnostic catheterization procedure
Intervention includes diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.
Sponsors
Arstasis, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Bed Elevation Within 15 Minutes. | Post procedure | Successful bed elevation was defined as the ability to sit up at a 45 degree angle within 15 minutes (1-30 minutes window) following sheath removal and successful hemostasis, without re-bleeding. This outcome was evaluated in subjects in whom successful access with the Arstasis device was achieved. The outcome measurement is reported as percentage of subjects. |
| Time to Actual Discharge | Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours. | The time from sheath removal to actual hospital discharge. |
| Time to Ambulation | Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated. | Time to ambulation was recorded as the difference between the time the procedural sheath is removed from the femoral artery and the time when the subject stands and walks at least 20 feet without re-bleeding. |
| Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events. | Procedure through 30 days follow-up. | — |
| Major Adverse Events Reported as Percentage of Participants With Adverse Events. | Procedure through 30 day follow-up. | Observation of any major access site-related complication (percentage of participants). |
| Device Success | Procedure | Achievement of femoral artery access using the Arstasis Access System followed by placement of the procedural sheath in the femoral artery. |
| Minor Adverse Events | Procedure through 30 day follow-up. | Observation of any minor access site-related complications. |
| Time to Hemostasis | Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved. | The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed. |
| Time to Discharge Eligibility | Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site. | The time from sheath removal to the time when the subject was medically able to be discharged based solely on the assessment of the access site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Ambulation | Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated. | Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression. |
| Time to Hemostasis | Hemostasis was evaluated immediately following procedural sheath removal. | Time to hemostasis for the diagnostic cohort, compared to published literature rates of 17 minutes for time to hemostasis for standard manual compression. |
Countries
United States
Participant flow
Recruitment details
Enrollment commenced November 3, 2010 and concluded June 3, 2011. Patients who underwent routine diagnostic catheterization through 5 or 6F sheaths were enrolled in the study at 8 investigational sites in the US.
Pre-assignment details
Patients were required to be able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.
Participants by arm
| Arm | Count |
|---|---|
| Intent to Treat | 346 |
| Sheath Greater Than 6F | 5 |
| Total | 351 |
Baseline characteristics
| Characteristic | Sheath Greater Than 6F | Intent to Treat | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 185 Participants | 186 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 161 Participants | 165 Participants |
| Age Continuous | 63.2 years STANDARD_DEVIATION 11.7 | 64.4 years STANDARD_DEVIATION 10.8 | 64.3 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 5 participants | 346 participants | 351 participants |
| Sex: Female, Male Female | 2 Participants | 151 Participants | 153 Participants |
| Sex: Female, Male Male | 3 Participants | 195 Participants | 198 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 346 | 0 / 5 |
| serious Total, serious adverse events | 0 / 346 | 0 / 5 |
Outcome results
Primary
Device Success
Achievement of femoral artery access using the Arstasis Access System followed by placement of the procedural sheath in the femoral artery.
Time frame: Procedure
Population: Intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent to Treat | Device Success | 97 Percentage of participants |
| Sheath Greater Than 6F | Device Success | 100 Percentage of participants |
Primary
Major Adverse Events Reported as Percentage of Participants With Adverse Events.
Observation of any major access site-related complication (percentage of participants).
Time frame: Procedure through 30 day follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent to Treat | Major Adverse Events Reported as Percentage of Participants With Adverse Events. | 0 Percentage of participants |
| Sheath Greater Than 6F | Major Adverse Events Reported as Percentage of Participants With Adverse Events. | 0 Percentage of participants |
Primary
Minor Adverse Events
Observation of any minor access site-related complications.
Time frame: Procedure through 30 day follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent to Treat | Minor Adverse Events | 4.0 Percentage of participants |
| Sheath Greater Than 6F | Minor Adverse Events | 0 Percentage of participants |
Primary
Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.
Time frame: Procedure through 30 days follow-up.
Primary
Percentage of Participants With Bed Elevation Within 15 Minutes.
Successful bed elevation was defined as the ability to sit up at a 45 degree angle within 15 minutes (1-30 minutes window) following sheath removal and successful hemostasis, without re-bleeding. This outcome was evaluated in subjects in whom successful access with the Arstasis device was achieved. The outcome measurement is reported as percentage of subjects.
Time frame: Post procedure
Population: Per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent to Treat | Percentage of Participants With Bed Elevation Within 15 Minutes. | 99.6 Percentage of participants |
| Sheath Greater Than 6F | Percentage of Participants With Bed Elevation Within 15 Minutes. | 20 Percentage of participants |
Primary
Time to Actual Discharge
The time from sheath removal to actual hospital discharge.
Time frame: Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours.
Population: Per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent to Treat | Time to Actual Discharge | 9.3 Hours | Standard Deviation 22.1 |
| Sheath Greater Than 6F | Time to Actual Discharge | 12.8 Hours | Standard Deviation 11.8 |
Primary
Time to Ambulation
Time to ambulation was recorded as the difference between the time the procedural sheath is removed from the femoral artery and the time when the subject stands and walks at least 20 feet without re-bleeding.
Time frame: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.
Population: Per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent to Treat | Time to Ambulation | 2.0 Hours | Standard Deviation 2.1 |
| Sheath Greater Than 6F | Time to Ambulation | 1.8 Hours | Standard Deviation 0.5 |
Primary
Time to Discharge Eligibility
The time from sheath removal to the time when the subject was medically able to be discharged based solely on the assessment of the access site.
Time frame: Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.
Population: Per Protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent to Treat | Time to Discharge Eligibility | 6.0 Hours | Standard Deviation 7.6 |
| Sheath Greater Than 6F | Time to Discharge Eligibility | 10.7 Hours | Standard Deviation 9.9 |
Primary
Time to Hemostasis
The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed.
Time frame: Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved.
Population: Per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent to Treat | Time to Hemostasis | 4.8 Minutes | Standard Deviation 3.7 |
| Sheath Greater Than 6F | Time to Hemostasis | 6.0 Minutes | Standard Deviation 4.2 |
Secondary
Time to Ambulation
Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression.
Time frame: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.
Population: Per Protocol-Diagnostic Cohort.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent to Treat | Time to Ambulation | 1.5 Hours | Standard Deviation 1.2 |
Secondary
Time to Hemostasis
Time to hemostasis for the diagnostic cohort, compared to published literature rates of 17 minutes for time to hemostasis for standard manual compression.
Time frame: Hemostasis was evaluated immediately following procedural sheath removal.
Population: Per protocol-Diagnostic Cohort.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent to Treat | Time to Hemostasis | 4.0 Minutes | Standard Deviation 2.5 |