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NCT00880230 · ClinicalTrials.gov registry record · NA

Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)

A NA study, sponsored by Medtronic Endovascular.

Completed
Registry status
NA
Development phase
141
Enrollment target

NCT00880230: Completed NA study, sponsored by Medtronic Endovascular.

NCT00880230 is a NA study that has completed, run by Medtronic Endovascular. The registered enrollment target is 141 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.

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The verdict

NCT00880230, a NA study, has completed, sponsored by Medtronic Endovascular.

COMPLETED
Registry status
NA
Development phase
141 participants
Enrollment target

Study Summary

The purpose of this study is to determine the safety and effectiveness of the Scuba™ stent in subjects with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.

Primary Outcome

The analysis is based on the percentage of Intent to Treat subjects (ITT) who experienced the primary endpoint or who had adequate follow-up for the 9-month analysis. A subject had adequate follow-up if he/she had an event or had a follow-up of at least 256 days, allowing for a visit window of 9 months +/- 14 days.

Interventions

  • DEVICE Scuba Iliac Stent System

Trial Details

FieldValue
Enrollment Target 141 participants
Start Date 2009-03
Est. Completion 2012-12
Phase NA
Medtronic Endovascular

25 total trials

What the finished NCT00880230 record still lists

NCT00880230 is an interventional study that assigns participants to a tested intervention. The registered 141 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 1 intervention - of which Scuba Iliac Stent System is the first listed.

NCT00880230 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00880230 about?

NCT00880230 is a clinical study titled "Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)". The purpose of this study is to determine the safety and effectiveness of the Scuba™ stent in subjects with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.

What is the current status of trial NCT00880230?

This trial is currently completed. It is a NA study. The enrollment target is 141 participants. The study started on 2009-03. Estimated completion is 2012-12.

What interventions are being tested in trial NCT00880230?

The interventions under investigation include: Scuba Iliac Stent System (DEVICE).

Who is sponsoring clinical trial NCT00880230?

This trial is sponsored by Medtronic Endovascular, which has 25 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00880230's enrollment target sits among peer trials

141 712th of 2000 higher than 1,288 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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Source: ClinicalTrials.gov NCT00880230, the US trial registry maintained by the National Library of Medicine. NCT00880230 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.