Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents
Public ClinicalTrials.gov record NCT01319812. 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
The Treatment of Iliac and Femoral Atherosclerotic Lesions Using the Self-expanding Astron and Pulsar Stents
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.
Study identification
- NCT ID
- NCT01319812
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 463 participants
Conditions and interventions
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
- Jul 2011 (Type not available)
- Primary completion
- Sep 2015 (Actual)
- Completion
- Sep 7, 2017 (Actual)
- Last update posted
- Mar 21, 2019
2011 – 2017
United States locations
- U.S. sites
- 33
- U.S. states
- 18
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Fremont | California | 94538 | — |
| Not listed | New Haven | Connecticut | 06510 | — |
| Not listed | Washington D.C. | District of Columbia | 20010 | — |
| Not listed | Rockford | Illinois | 61107 | — |
| Not listed | Munster | Indiana | 46321 | — |
| Not listed | Houma | Louisiana | 70360 | — |
| Not listed | Lansing | Michigan | 48912 | — |
| Not listed | Saginaw | Michigan | 48601 | — |
| Not listed | Wyoming | Michigan | 49519 | — |
| Not listed | Ypsilanti | Michigan | 48197 | — |
| Not listed | Tupelo | Mississippi | 38801 | — |
| Not listed | Kansas City | Missouri | 64114 | — |
| Not listed | Ridgewood | New Jersey | 07450 | — |
| Not listed | New York | New York | 10065 | — |
| Not listed | The Bronx | New York | 10467 | — |
| Not listed | Gastonia | North Carolina | 28054 | — |
| Not listed | High Point | North Carolina | 27262 | — |
| Not listed | Cincinnati | Ohio | 45267 | — |
| Not listed | Toledo | Ohio | 43606 | — |
| Not listed | Toledo | Ohio | 43614 | — |
| Not listed | Camp Hill | Pennsylvania | 17011 | — |
| Not listed | Doylestown | Pennsylvania | 18901 | — |
| Not listed | Langhorne | Pennsylvania | 19047 | — |
| Not listed | Pittsburgh | Pennsylvania | 15232 | — |
| Not listed | Providence | Rhode Island | 02906 | — |
| Not listed | Greenville | South Carolina | 29605 | — |
| Not listed | Rock Hill | South Carolina | 29732 | — |
| Not listed | Kingsport | Tennessee | 37660 | — |
| Not listed | Amarillo | Texas | 79106 | — |
| Not listed | Austin | Texas | 78745 | — |
| Not listed | McKinney | Texas | 75069 | — |
| Not listed | Tyler | Texas | 75701 | — |
| Not listed | Waco | Texas | 76712 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01319812, 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 Mar 21, 2019 · 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 NCT01319812 live on ClinicalTrials.gov.