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NCT01983449 · ClinicalTrials.gov registry record · Phase 4

Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease

A Phase 4 study, sponsored by Mercator MedSystems.

Completed
Registry status
Phase 4
Development phase
285
Enrollment target

NCT01983449: Completed Phase 4 study, sponsored by Mercator MedSystems.

NCT01983449 is a Phase 4 study that has completed, run by Mercator MedSystems. The registered enrollment target is 285 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01983449, a Phase 4 study, has completed, sponsored by Mercator MedSystems.

COMPLETED
Registry status
Phase 4
Development phase
285 participants
Enrollment target

Study Summary

To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the superficial femoral and/or popliteal arteries. Study Drug and Dose: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/ml, with dilute contrast (17%) administered to the adventitia in a dose of 1.6 mg per cm of desired vessel treatment length.

Interventions

  • DRUG Dexamethasone Sodium Phosphate Injection, USP

Trial Details

FieldValue
Enrollment Target 285 participants
Start Date 2013-11
Est. Completion 2018-01
Phase Phase 4

Sponsor

Mercator MedSystems

7 total trials

What the Registry Record Tells You About NCT01983449

The ClinicalTrials.gov registry entry for NCT01983449 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 285 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mercator MedSystems, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Dexamethasone Sodium Phosphate Injection, USP is the first listed.

NCT01983449 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01983449 about?

NCT01983449 is a clinical study titled "Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease". To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the superficial femoral and/or popliteal arteries. St...

What is the current status of trial NCT01983449?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 285 participants. The study started on 2013-11. Estimated completion is 2018-01.

What interventions are being tested in trial NCT01983449?

The interventions under investigation include: Dexamethasone Sodium Phosphate Injection, USP (DRUG).

Who is sponsoring clinical trial NCT01983449?

This trial is sponsored by Mercator MedSystems, which has 7 total clinical trials registered on ClinicalTrials.gov.

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

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, the data changelog, or report a data error.