Femoral Micropuncture or Routine Introducer Study

NCT01103141 | Terminated Results

• 1 other identifier: 09-012
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 2

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.

Conditions

Complications

Keywords

Vascular Surgical Procedures; Angioplasty; Radiology, Interventional

Outcome Measures

Primary Outcomes (1)

• 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

  7 - 14 days

Study Arms (2)

Micropuncture

ACTIVE COMPARATOR

Device: Micropuncture needle set

Standard

ACTIVE COMPARATOR

Device: Standard gauge-18 needle set

Interventions

Micropuncture needle set DEVICE

Groin access for vascular intervention

Micropuncture

Standard gauge-18 needle set DEVICE

Groin access for vascular intervention

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing left heart catheterization with anticipated or possible percutaneous coronary intervention

You may not qualify if:

• 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

Sponsors & Collaborators

• Cook Group Incorporated: lead

Study Sites (2)

University of California, San Francisco, Fresno, School of Medicine

Fresno, California, 93701, United States

Location

St. Vincent Hospital

Indianapolis, Indiana, 46290, United States

Location

Results Point of Contact

• Title: Scott Snyder, PhD, Director of Clinical Affairs
• Organization: Cook Research Incorporated

Scott.Snyder@CookMedical.com

765-463-7537

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 14, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 11, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-04

Locations

US (2)