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NCT00534859 · ClinicalTrials.gov registry record · Phase 2

PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

A Phase 2 study, sponsored by Abiomed.

Completed
Registry status
Phase 2
Development phase
28
Enrollment target

NCT00534859 is a Phase 2 study that has completed, run by Abiomed. The registered enrollment target is 28 participants.

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The verdict

NCT00534859, a Phase 2 study, has completed, sponsored by Abiomed.

COMPLETED
Registry status
Phase 2
Development phase
28 participants
Enrollment target

Study Summary

The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion \& exclusion criteria.

Interventions

  • DEVICE High Risk PCI

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2006-08
Est. Completion 2011-03
Phase Phase 2

Sponsor

Abiomed

20 total trials

What the Registry Record Tells You About NCT00534859

The ClinicalTrials.gov registry entry for NCT00534859 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abiomed, which has 20 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which High Risk PCI is the first listed.

NCT00534859 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00534859 about?

NCT00534859 is a clinical study titled "PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI". The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion \& exclusion criteria.

What is the current status of trial NCT00534859?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2006-08. Estimated completion is 2011-03.

What interventions are being tested in trial NCT00534859?

The interventions under investigation include: High Risk PCI (DEVICE).

Who is sponsoring clinical trial NCT00534859?

This trial is sponsored by Abiomed, which has 20 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.