Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions
Public ClinicalTrials.gov record NCT01092416. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360°® Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01092416
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 443 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2010 (Type not available)
- Primary completion
- Jan 2013 (Actual)
- Completion
- Jan 2016 (Actual)
- Last update posted
- Jul 18, 2023
2010 – 2016
United States locations
- U.S. sites
- 51
- U.S. states
- 24
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Trinity Hospital | Birmingham | Alabama | 35213 | — |
| Baptist Montgomery South | Montgomery | Alabama | 36116 | — |
| Mercy Gilbert | Gilbert | Arizona | 85297 | — |
| Cedar Sinai Los Angeles | Beverly Hills | California | 90210 | — |
| Good Samaritan Hospital | Los Angeles | California | 90017 | — |
| Eisenhower Medical Center | Palm Springs | California | 92270 | — |
| Desert Cardiology Center | Rancho Mirage | California | 92270 | — |
| Sutter Memorial Hospital | Sacramento | California | 95825 | — |
| Florida Hospital Memorial | Daytona Beach | Florida | 32117 | — |
| North Florida Regional | Gainesville | Florida | 32614 | — |
| Munroe Regional Medical Center | Ocala | Florida | 34471 | — |
| Florida Hospital | Orlando | Florida | 32803 | — |
| Orlando Regional | Orlando | Florida | 32806 | — |
| Palm Beach Gardens | Palm Beach Gardens | Florida | 33410 | — |
| Winter Haven | Winter Haven | Florida | 33881 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Indiana Heart Hospital | Indianapolis | Indiana | 46250 | — |
| Saint Vincents Indianapolis | Indianapolis | Indiana | 46290 | — |
| Community Hospital | Munster | Indiana | 46321 | — |
| Iowa Heart | Des Moines | Iowa | 50314 | — |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | — |
| King's Daughters / Kentucky Heart Foundation | Ashland | Kentucky | 41101 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Cape Cod Research Institute | Hyannis | Massachusetts | 02601 | — |
| Detroit Medical Center | Detroit | Michigan | 48201-2018 | — |
| St. John's Hospital | Detroit | Michigan | 48236 | — |
| St. Joseph Mercy | Pontiac | Michigan | 48341 | — |
| Lakeland | Saint Joseph | Michigan | 49085 | — |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | — |
| Abbott Northwestern | Minneapolis | Minnesota | 55407 | — |
| United Heart & Vascular | Saint Paul | Minnesota | 55102 | — |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | — |
| Saint Michaels | Newark | New Jersey | 07102 | — |
| Valley Hospital | Ridgewood | New Jersey | 07450 | — |
| New York Methodist Hospital | Brooklyn | New York | 71878 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Lenox Hill | New York | New York | 10075 | — |
| St. Francis | Roslyn | New York | 11576 | — |
| Good Samaritan Dayton | Dayton | Ohio | 45405 | — |
| Oklahoma Heart | Oklahoma City | Oklahoma | 73120 | — |
| The Heart and Vascular Center | Beaver | Pennsylvania | 15009 | — |
| Bryn Mawr / Lankenau | Bryn Mawr | Pennsylvania | 19010 | — |
| St. Mary's | Langhorne | Pennsylvania | 19047 | — |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Baptist Memorial Hospital-DeSoto | Memphis | Tennessee | 38120 | — |
| Baylor | Dallas | Texas | 75226 | — |
| Memorial Hermann | Houston | Texas | 77030 | — |
| St. Luke's | Houston | Texas | 77030 | — |
| Davis Hospital | Layton | Utah | 84041 | — |
| Saint Joe Bellingham / North Cascade Cardiology | Bellingham | Washington | 98225 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01092416, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 18, 2023 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01092416 live on ClinicalTrials.gov.