Complications
Conditions
Keywords
Vascular Surgical Procedures, Angioplasty, Radiology, Interventional
Brief summary
FEMORIS is a marketing study approved by institutional review boards to compare the rates of complications found when using either the Micropuncture® needle introducer or a standard gauge-18 needle to access the groin blood vessels.
Interventions
DEVICEMicropuncture needle set
Groin access for vascular intervention
DEVICEStandard gauge-18 needle set
Groin access for vascular intervention
Sponsors
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing left heart catheterization with anticipated or possible percutaneous coronary intervention
Exclusion criteria
* Left heart cardiac catheterization purely for diagnostic purposes where percutaneous coronary intervention is not anticipated * Catheterization utilizes primary vascular access site other than the groin * Catheterization is intended for right heart procedure alone or combined with left and right heart procedures * Age less than 18 years * Patient has planned intervention or access utilizing the same groin within 14 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Peripheral Vascular Events | 7 - 14 days | Major peripheral vascular events occurring during femoral catheterization followed by Percutaneous Coronary Intervention (PCI), which include any of the following: Groin bleeding, including oozing or spurting after standard compression time necessitating further compression; Groin hematoma ≥ 5 cm at any time during or after the procedure; Pseudoaneurysm, confirmed by Doppler ultrasound; Arteriovenous (AV) fistula, confirmed by Doppler ultrasound; Arterial dissection, thrombosis, or embolism; Retroperitoneal bleeding defined by Computed Tomography Angiography (CTA) or surgery; Significant drop in hemoglobin ≥ 3 g/dL, or a drop in hematocrit ≥ 10% within 24-48 hours after the procedure compared to baseline without an obvious non-groin source; Any groin complication delaying hospital discharge; Large ecchymosis (\> 15 cm) at the site of vascular access on follow-up (dark purple to black and confluent ecchymoses); Obvious extravascular extravasation of contrast as noted on the femoral |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Micropuncture Gauge-21 Micropuncture® needle | 67 |
| Routine Access Standard gauge-18 large-bore needle | 76 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Micropuncture | Routine Access | Total |
|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 11.3 | 63 years STANDARD_DEVIATION 12.3 | 62.3 years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 19 Participants | 30 Participants | 49 Participants |
| Sex: Female, Male Male | 48 Participants | 46 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 67 | 15 / 76 |
| serious Total, serious adverse events | 0 / 67 | 1 / 76 |
Outcome results
Primary
Major Peripheral Vascular Events
Major peripheral vascular events occurring during femoral catheterization followed by Percutaneous Coronary Intervention (PCI), which include any of the following: Groin bleeding, including oozing or spurting after standard compression time necessitating further compression; Groin hematoma ≥ 5 cm at any time during or after the procedure; Pseudoaneurysm, confirmed by Doppler ultrasound; Arteriovenous (AV) fistula, confirmed by Doppler ultrasound; Arterial dissection, thrombosis, or embolism; Retroperitoneal bleeding defined by Computed Tomography Angiography (CTA) or surgery; Significant drop in hemoglobin ≥ 3 g/dL, or a drop in hematocrit ≥ 10% within 24-48 hours after the procedure compared to baseline without an obvious non-groin source; Any groin complication delaying hospital discharge; Large ecchymosis (\> 15 cm) at the site of vascular access on follow-up (dark purple to black and confluent ecchymoses); Obvious extravascular extravasation of contrast as noted on the femoral
Time frame: 7 - 14 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Micropuncture | Major Peripheral Vascular Events | Ecchymosis > 15 cm | 6 participants |
| Micropuncture | Major Peripheral Vascular Events | Groin bleeding | 4 participants |
| Micropuncture | Major Peripheral Vascular Events | Groin hematoma | 2 participants |
| Routine Access | Major Peripheral Vascular Events | Groin bleeding | 5 participants |
| Routine Access | Major Peripheral Vascular Events | Groin hematoma | 5 participants |
| Routine Access | Major Peripheral Vascular Events | Ecchymosis > 15 cm | 5 participants |