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NCT01092416 · ClinicalTrials.gov registry record · NA
Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 443
- Enrollment target
NCT01092416 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 443 participants.
The verdict
NCT01092416, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 443 participants
- Enrollment target
Study Summary
This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects. Study is going to enroll up to 429 subjects in up to 50 U.S. study sites. The primary safety endpoint is 30-day MACE and primary efficacy endpoint is procedural success. All subjects will be treated with the orbital atherectomy system and adjunctive stent. All subjects will be followed in clinic at 30 days. Additionally, all subjects will have an annual phone call or clinical follow up at each anniversary until study is closed.
Interventions
- DEVICE Diamondback 360 Orbital Atherectomy System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 443 participants |
| Start Date | 2010-05 |
| Est. Completion | 2016-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01092416
The ClinicalTrials.gov registry entry for NCT01092416 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 443 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Diamondback 360 Orbital Atherectomy System is the first listed.
NCT01092416 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01092416 about?
NCT01092416 is a clinical study titled "Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions". This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects. Study is going to enroll up to 429 subjects in up to 50 U.S. study sites. The primary safety endpoint is 30-day MACE and...
What is the current status of trial NCT01092416?
This trial is currently completed. It is a NA study. The enrollment target is 443 participants. The study started on 2010-05. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01092416?
The interventions under investigation include: Diamondback 360 Orbital Atherectomy System (DEVICE).
Who is sponsoring clinical trial NCT01092416?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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