Vascular Closure
Conditions
Brief summary
This study evaluates the safety and effectiveness of the Cross-Seal vascular closure device in gaining post procedure hemostasis in subjects undergoing interventional procedures requiring an 8 to 18 french size introducer sheath.
Detailed description
The Cross-Seal device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (8-18F ID) interventional devices. The function of Cross-Seal is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure. The study is being conducted to demonstrate the safety and effectiveness of Cross-Seal in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.
Interventions
DEVICECross-Seal System
Use of the Cross-Seal system to close the femoral arteriotomy
Sponsors
Terumo Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Performance goal
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥ 18 years old 2. Subject is scheduled for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedures involving access through the femoral artery using 8-18 French introducer sheaths 3. Subject is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery 4. Subject is willing and able to complete follow-up requirements 5. Subject, or authorized representative signs a written Informed Consent form prior participating in the study
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time To Hemostasis (TTH) | Index Procedure | The mean Time To Hemostasis in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device. |
| Freedom From Major Complications | 30 days post procedure | Freedom from major complications of the target limb. Major Complications include: access site vascular injury that requires surgical intervention, access related lower extremity ischemia, access site infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device Related Complications Within 30 Days Post-procedure | 30 days post procedure | Number of subjects with devices related complications as adjudicated by the Clinical Events Committee. |
| Incidence of Adverse Events | 60 days post procedure | Incidence of major and minor Adverse Events (AEs) |
| Incidence of Technical Success | Immediately Post-procedure (procedure approximately 8 hours) | Incidence of hemostasis with the investigational device without the need for any access-site-related adjunctive surgical or endovascular intervention (target limb only). |
| Incidence of Closure Success | Within 48 hours of the index procedure or hospital discharge, whichever occurs first | Incidence of access site closure success: defined as technical success and freedom from major complications |
| Incidence of Device Failure | 30 days post procedure | Incidence of subjects experiencing Device Failure. |
| Incidence of Surgical or Endovascular Intervention Post Closure | 30 days post procedure | Subjects requiring adjunctive surgical or endovascular intervention to achieve hemostasis of the access site (target limb only) including type of adjunctive intervention. |
| Incidence of Manual Compression | Post-procedure, following use of the investigational device until achieve hemostasis, assessed approximately up to 48 hours | Incidence of subjects requiring adjunctive manual compression following use of the investigational device to achieve hemostasis of the access site (target limb only). |
| Time-to-Ambulation: | From the final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding, assessed up to approximately 48 hours | Time-to-Ambulation: defined as elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding. |
| Incidence of Procedure Related Complications | 30 days post procedure | Number of subjects with procedure related complications as adjudicated by the CEC. |
| Incidence of Treatment Success | 30 days post procedure | Incidence of Treatment Success: defined as technical success and freedom from major complications |
| Freedom From Minor Complications | 30 days post procedure | The freedom from minor complications at the target limb access site. Minor Complications include: pseudoaneurysm at the access site, access site hematoma over 10cm, access site wound dehiscence |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transfemoral Approach Closure of Common Femoral Artery site of subjects who have undergone interventional catheterization procedure using 8-18FR ID sheaths. | 147 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Transfemoral Approach |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 130 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 76.0 years STANDARD_DEVIATION 10.05 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 132 Participants |
| Region of Enrollment United States | 147 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 147 |
| other Total, other adverse events | 63 / 147 |
| serious Total, serious adverse events | 42 / 147 |
Outcome results
Primary
Freedom From Major Complications
Freedom from major complications of the target limb. Major Complications include: access site vascular injury that requires surgical intervention, access related lower extremity ischemia, access site infection
Time frame: 30 days post procedure
Population: Pivotal safety cohort included 96 subjects from the full analysis set, comprising all enrolled and treated subjects who experienced at least one component for the safety endpoint or were follow-up to the lower limit of the follow-up window for each time point. Due to missing data from 8 subjects, the analysis was conducted with 88 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transfemoral Approach | Freedom From Major Complications | 83 Participants |
Primary
Mean Time To Hemostasis (TTH)
The mean Time To Hemostasis in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device.
Time frame: Index Procedure
Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Number of participants analyzed is 101 as 9 subjects who had an adjunctive intervention and 4 subjects who did not receive the investigational device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transfemoral Approach | Mean Time To Hemostasis (TTH) | 0.4 Minutes | Standard Deviation 1.4 |
Secondary
Freedom From Minor Complications
The freedom from minor complications at the target limb access site. Minor Complications include: pseudoaneurysm at the access site, access site hematoma over 10cm, access site wound dehiscence
Time frame: 30 days post procedure
Population: Pivotal safety cohort included 96 subjects from full analysis set, comprising all enrolled and treated subjects who experienced at least one component for the safety endpoint or were follow-up to the lower limit of the follow-up window for each time point. Due to missing data from 8 subjects, the analysis was conducted with 88 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transfemoral Approach | Freedom From Minor Complications | 84 Participants |
Secondary
Incidence of Adverse Events
Incidence of major and minor Adverse Events (AEs)
Time frame: 60 days post procedure
Population: Pivotal safety cohort included 96 subjects from full analysis set, comprising all enrolled and treated subjects who experienced at least one component for the safety endpoint or were follow-up to the lower limit of the follow-up window for each time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transfemoral Approach | Incidence of Adverse Events | 62 Participants |
Secondary
Incidence of Closure Success
Incidence of access site closure success: defined as technical success and freedom from major complications
Time frame: Within 48 hours of the index procedure or hospital discharge, whichever occurs first
Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 2 subjects, the analysis was conducted on 112 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transfemoral Approach | Incidence of Closure Success | 99 Participants |
Secondary
Incidence of Device Failure
Incidence of subjects experiencing Device Failure.
Time frame: 30 days post procedure
Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transfemoral Approach | Incidence of Device Failure | 0 Participants |
Secondary
Incidence of Manual Compression
Incidence of subjects requiring adjunctive manual compression following use of the investigational device to achieve hemostasis of the access site (target limb only).
Time frame: Post-procedure, following use of the investigational device until achieve hemostasis, assessed approximately up to 48 hours
Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 3 subjects, the analysis was conducted on 111 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transfemoral Approach | Incidence of Manual Compression | 31 Participants |
Secondary
Incidence of Procedure Related Complications
Number of subjects with procedure related complications as adjudicated by the CEC.
Time frame: 30 days post procedure
Population: Pivotal safety cohort included 96 subjects from full analysis set, comprising all enrolled and treated subjects who experienced at least one component for the safety endpoint or were follow-up to the lower limit of the follow-up window for each time point. Due to missing data from 8 subjects, the analysis was conducted with 88 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transfemoral Approach | Incidence of Procedure Related Complications | 9 Participants |
Secondary
Incidence of Surgical or Endovascular Intervention Post Closure
Subjects requiring adjunctive surgical or endovascular intervention to achieve hemostasis of the access site (target limb only) including type of adjunctive intervention.
Time frame: 30 days post procedure
Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 4 subjects, the analysis was conducted on 110 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transfemoral Approach | Incidence of Surgical or Endovascular Intervention Post Closure | 8 Participants |
Secondary
Incidence of Technical Success
Incidence of hemostasis with the investigational device without the need for any access-site-related adjunctive surgical or endovascular intervention (target limb only).
Time frame: Immediately Post-procedure (procedure approximately 8 hours)
Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 4 subjects, the analysis was conducted on 110 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transfemoral Approach | Incidence of Technical Success | 102 Participants |
Secondary
Incidence of Treatment Success
Incidence of Treatment Success: defined as technical success and freedom from major complications
Time frame: 30 days post procedure
Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 3 subjects, the analysis was conducted on 111 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transfemoral Approach | Incidence of Treatment Success | 98 Participants |
Secondary
Number of Participants With Device Related Complications Within 30 Days Post-procedure
Number of subjects with devices related complications as adjudicated by the Clinical Events Committee.
Time frame: 30 days post procedure
Population: Pivotal safety cohort included 96 subjects from full analysis set, comprising all enrolled and treated subjects who experienced at least one component for the safety endpoint or were follow-up to the lower limit of the follow-up window for each time point. Due to missing data from 8 subjects, the analysis was conducted with 88 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transfemoral Approach | Number of Participants With Device Related Complications Within 30 Days Post-procedure | 9 Participants |
Secondary
Time-to-Ambulation:
Time-to-Ambulation: defined as elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding.
Time frame: From the final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding, assessed up to approximately 48 hours
Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 6 subjects, the analysis was conducted on 108 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transfemoral Approach | Time-to-Ambulation: | 15.9 Hours | Standard Deviation 14.65 |