Clinical Trials Logo
  1. Home
  2. Complications
  3. NCT01103141
  4. Details
NCT01103141 Clinical Trial

Femoral Micropuncture or Routine Introducer Study

Complications Clinical Trial

— FEMORIS  

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01103141
Other study ID # 09-012
Secondary ID
Status Terminated
Phase N/A
First received April 12, 2010
Last updated February 3, 2015
Start date June 2010
Est. completion date April 2011

Study information
Verified date February 2015
Source Cook
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 144
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Device:
• Micropuncture needle set
Groin access for vascular intervention
• Standard gauge-18 needle set
Groin access for vascular intervention

Locations
Country Name City State
United States University of California, San Francisco, Fresno, School of Medicine Fresno California
United States St. Vincent Hospital Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Cook

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of access site complications 7 - 14 days Yes
See also
  Status Clinical Trial Phase
Recruiting NCT02246153 - Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients Phase 3
Recruiting NCT02228473 - Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort N/A
Recruiting NCT01917253 - Standard Length Catheters vs Long Catheters in Peripheral Vein Cannulation. N/A
Completed NCT02245854 - Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps N/A
Completed NCT01574196 - Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood N/A
Completed NCT02447523 - The Impact of Metabolic Syndrome on Patients Undergoing Elective Laparotomy N/A
Terminated NCT00616824 - The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction Phase 4
Completed NCT04061655 - Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion Early Phase 1
Recruiting NCT03984747 - Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection
Completed NCT03641365 - Sleeves Versus Sleeveless Template N/A
Completed NCT02901665 - Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes N/A
Completed NCT02675166 - Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes
Not yet recruiting NCT02252445 - Propofol and Sevoflurane for Catheter-Related Bladder Discomfort N/A
Completed NCT01997658 - Preoperative Glucocorticoid Use in Major Hepatectomy Phase 2/Phase 3
Active, not recruiting NCT01775150 - Saving Mother and Baby With Text Messaging N/A
Completed NCT01631799 - Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia N/A
Completed NCT03440138 - Defining Benchmarks in Bariatric Surgery
Recruiting NCT02835404 - Pelvic External Combined With 252-Cf Neutron Intracavitary Radiotherapy With or Without Platinum in Treating Advanced Cervical Cancer Phase 2
Completed NCT01489800 - The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer N/A
Completed NCT02096224 - Sevoflurane Versus Desflurane for Catheter-related Bladder Discomfort N/A