Femoral Arteriotomy Closure
Conditions
Keywords
Vascular Closure Device, Femoral Artery Closure
Brief summary
The study is designed to prospectively collect data on and confirm the safety and effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and time to ambulation for patients who have undergone diagnostic or interventional catheterization procedures using up to 6F sheaths when compared with standard compression techniques using data from literature surveys.
Interventions
DEVICEX-Seal 6F Vascular Closure Device
Sponsors
Essential Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Candidate for non-emergent diagnostic or interventional cardiac catheterization via a femoral sheath ≤6F. * Age ≥18 years. * Understand and sign the study specific written informed consent form. * In the investigator's opinion, the patient is suitable for the X-Seal vascular closure device, conventional hemostasis techniques and participation in an investigational trial. * Eligible for sheath removal in the catheterization lab.
Exclusion criteria
* Patients who are known to be pregnant or lactating. * Patients who are immunocompromised. * Prior target artery closure with any vascular closure device or closure with manual compression win 30 days prior to this procedure. * Patients with significant anemia (hemoglobin \<10 g/DL, Hct\<30). * Patients who are morbidly obese or cachectic (BMI \>40 or \<20 kg/m2). * Patients with Systolic Blood Pressure \>180 mmHg, unless Systolic Pressure can be lowered by pharmacological agents prior to closure * Patients who are currently participating in another clinical trial of an investigational drug or device that has not concluded the follow-up period. * Patients with a baseline INR \> 1.5 (e.g. coumadin therapy). * Patients with a known bleeding disorder including thrombocytopenia (platelet count \<100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand's disease. * Patients with small femoral arteries (\<4 mm), femoral artery stenosis resulting in a vessel diameter \<4 mm, or patients with severe peripheral vascular disease. * Patients with puncture site believed to be in the profunda femoris, superficial femoral artery, or at the bifurcation of the arteries. * Common femoral artery with fluoroscopically visible calcium. * Femoral arteries that are suspected to have experienced a back wall puncture or that underwent \>one (1) arterial puncture during the catheterization procedure. * Patients having a complication(s) at the femoral artery access site pre-sheath removal including hematoma, pseudoaneurysm, or arterio-venous fistula. * Patients in whom continued heparin or other anticoagulant/antiplatelet therapy is planned (with the exception of Glycoprotein IIb/IIIa receptor blockers) following completion of the catheterization procedure. * Patients whose ACT is \>300 seconds prior to removal of the guiding catheter. * Patients who cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence or life threatening disease. * Prior femoral vascular surgery or vascular graft in region of access site. * Patient is unable to ambulate at baseline. * Acute ST-elevation MI within 48 hours prior to procedure. * Active systemic or cutaneous infection or inflammation * Patients with unilateral or bilateral lower extremity amputation * Patients with renal insufficiency (serum creatinine \>2.5 mg/dl) * Patients with marked tortuosity of the femoral or iliac artery * Patients in whom bacterial contamination of the procedure sheath or surrounding tissues may have occurred as this may result in infection * Patients in whom the puncture site is located above the most inferior border of the epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma/bleed. Perform a femoral angiogram to verify the location of the puncture site * Patients with known allergies to beef products, collagen and/or collagen products, or polyglycolic or polylactic acid polymers * Patients with known allergy to stainless steel or nickel. See MRI information in the IFU. * Patients undergoing therapeutic thrombolysis * Patients punctured through a vascular graft
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Complications | 30 days | The rate of major complications within approximately 30 days following the procedure. |
| Time-to-Hemostasis | Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding, assessed up to 2 hours. | Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-Ambulation | Ambulation will be assessed 1.5 hours after removal of the access sheath for Diagnostic Patients, and 3 hours after procedure sheath removal for Interventional Patients. | The time from end of the procedure until the patient ambulates for the first time. |
| Adverse Events | 30 days | The rate of adverse events within approximately 30 days following the procedure. All AEs counted, whether or not device-related. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic Patients treated with X-Seal device that were undergoing a diagnostic catheter procedure. | 22 |
| Interventional Patients treated with X-Seal device that underwent an interventional catheter procedure. | 17 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Guidewire Failure | 0 | 1 |
| Overall Study | Intra-procedural Exclusion | 1 | 3 |
| Overall Study | Screening Failure | 3 | 0 |
Baseline characteristics
| Characteristic | Diagnostic | Interventional | Total |
|---|---|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 13 | 66.3 years STANDARD_DEVIATION 11.8 | 65.1 years STANDARD_DEVIATION 12.4 |
| Ankle-Brachial Index (ABI) | 1.1 Ratio STANDARD_DEVIATION 0.1 | 1.0 Ratio STANDARD_DEVIATION 0.2 | 1.0 Ratio STANDARD_DEVIATION 0.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 17 Participants | 39 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Male | 14 Participants | 13 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 21 |
| other Total, other adverse events | 1 / 26 | 6 / 21 |
| serious Total, serious adverse events | 1 / 26 | 4 / 21 |
Outcome results
Primary
Major Complications
The rate of major complications within approximately 30 days following the procedure.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic | Major Complications | 0 Participants |
| Interventional | Major Complications | 0 Participants |
Primary
Time-to-Hemostasis
Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding.
Time frame: Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding, assessed up to 2 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic | Time-to-Hemostasis | 0.36 Minutes | Standard Deviation 1.14 |
| Interventional | Time-to-Hemostasis | 0.65 Minutes | Standard Deviation 1.37 |
Secondary
Adverse Events
The rate of adverse events within approximately 30 days following the procedure. All AEs counted, whether or not device-related.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic | Adverse Events | 2 Participants |
| Interventional | Adverse Events | 8 Participants |
Secondary
Time-to-Ambulation
The time from end of the procedure until the patient ambulates for the first time.
Time frame: Ambulation will be assessed 1.5 hours after removal of the access sheath for Diagnostic Patients, and 3 hours after procedure sheath removal for Interventional Patients.
Population: Subjects for whom ambulation data are available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic | Time-to-Ambulation | 3.52 hours | Standard Deviation 1.09 |
| Interventional | Time-to-Ambulation | 3.16 hours | Standard Deviation 1.14 |