Trial Outcomes & Findings for Femoral Micropuncture or Routine Introducer Study (NCT NCT01103141)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

143 participants

Primary outcome timeframe

7 - 14 days

Results posted on

2017-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Micropuncture Gauge-21 Micropuncture® needle	Routine Access Standard gauge-18 large-bore needle
Overall Study STARTED	67	76
Overall Study COMPLETED	65	74
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Micropuncture Gauge-21 Micropuncture® needle	Routine Access Standard gauge-18 large-bore needle
Overall Study Death	0	1
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Femoral Micropuncture or Routine Introducer Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Micropuncture n=67 Participants Gauge-21 Micropuncture® needle	Routine Access n=76 Participants Standard gauge-18 large-bore needle	Total n=143 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 11.3 • n=5 Participants	63 years STANDARD_DEVIATION 12.3 • n=7 Participants	62.3 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	30 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	46 Participants n=7 Participants	94 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Micropuncture n=67 Participants Gauge-21 Micropuncture® needle	Routine Access n=76 Participants Standard gauge-18 large-bore needle
Major Peripheral Vascular Events Groin bleeding	4 participants	5 participants
Major Peripheral Vascular Events Groin hematoma	2 participants	5 participants
Major Peripheral Vascular Events Ecchymosis > 15 cm	6 participants	5 participants

Adverse Events

Micropuncture

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Routine Access

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Micropuncture n=67 participants at risk Gauge-21 Micropuncture® needle	Routine Access n=76 participants at risk Standard gauge-18 large-bore needle
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/67 • Up to 4 weeks	1.3% 1/76 • Number of events 1 • Up to 4 weeks

Other adverse events

Other adverse events
Measure	Micropuncture n=67 participants at risk Gauge-21 Micropuncture® needle	Routine Access n=76 participants at risk Standard gauge-18 large-bore needle
Injury, poisoning and procedural complications Ecchymosis > 15 cm	9.0% 6/67 • Number of events 6 • Up to 4 weeks	6.6% 5/76 • Number of events 5 • Up to 4 weeks
Injury, poisoning and procedural complications Groin bleeding	6.0% 4/67 • Number of events 4 • Up to 4 weeks	6.6% 5/76 • Number of events 5 • Up to 4 weeks
Injury, poisoning and procedural complications Groin hematoma	3.0% 2/67 • Number of events 2 • Up to 4 weeks	6.6% 5/76 • Number of events 5 • Up to 4 weeks

Additional Information

Scott Snyder, PhD, Director of Clinical Affairs

Cook Research Incorporated

Phone: 765-463-7537

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60