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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: Completed NA study, sponsored by Abbott Medical Devices.
NCT01092416 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 443 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
OAS safety was measured by a composite of MACE at 30-days post procedure. MACE is composed of: * Cardiac death. * MI - defined as a CK-MB level \> 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave. * TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure.
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 |
What the finished NCT01092416 record still lists
NCT01092416 is an interventional study that assigns participants to a tested intervention. The registered 443 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 (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Diamondback 360 Orbital Atherectomy System is the first listed.
NCT01092416 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01092416's enrollment target sits among peer trials
443 233rd of 2000 higher than 1,768 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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