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NCT01103141 · ClinicalTrials.gov registry record · NA
Femoral Micropuncture or Routine Introducer Study
A NA study, sponsored by Cook Group Incorporated.
- Terminated
- Registry status
- NA
- Development phase
- 143
- Enrollment target
NCT01103141: Clinical Trial NA study, sponsored by Cook Group Incorporated.
NCT01103141 is a NA study that was terminated before completion, run by Cook Group Incorporated. The registered enrollment target is 143 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01103141, a NA study, was terminated before completion, sponsored by Cook Group Incorporated.
- TERMINATED
- Registry status
- NA
- Development phase
- 143 participants
- Enrollment target
Study 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.
Primary Outcome
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; Ret
Interventions
- DEVICE Micropuncture needle set
- DEVICE Standard gauge-18 needle set
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-04 |
| Phase | NA |
Why NCT01103141 stopped before completion
NCT01103141 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Micropuncture needle set is the first listed.
NCT01103141 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01103141 about?
NCT01103141 is a clinical study titled "Femoral Micropuncture or Routine Introducer Study". 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.
What is the current status of trial NCT01103141?
This trial is currently terminated. It is a NA study. The enrollment target is 143 participants. The study started on 2010-06. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01103141?
The interventions under investigation include: Micropuncture needle set (DEVICE), Standard gauge-18 needle set (DEVICE).
Who is sponsoring clinical trial NCT01103141?
This trial is sponsored by Cook Group Incorporated, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01103141's enrollment target sits among peer trials
143 711th of 2000 higher than 1,290 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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