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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Acute safety safety outcomes will be determined by evaluating the type, frequency, severity, and relatedness of Major Adverse Limb Events or Peri-Operative Death (MALE+POD) within 30 days from the procedure for all subjects.
Interventions
- DRUG Dexamethasone Sodium Phosphate Injection, USP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2013-11 |
| Est. Completion | 2018-01 |
| Phase | Phase 4 |
What the finished NCT01983449 record still lists
NCT01983449 is an interventional study that assigns participants to a tested intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 1 intervention - of which Dexamethasone Sodium Phosphate Injection, USP is the first listed.
NCT01983449 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01983449's enrollment target sits among peer trials
285 302nd of 2000 higher than 1,699 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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