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NCT01319812 · ClinicalTrials.gov registry record · Phase 2
Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents
A Phase 2 study, sponsored by Biotronik.
- Completed
- Registry status
- Phase 2
- Development phase
- 463
- Enrollment target
NCT01319812: Completed Phase 2 study, sponsored by Biotronik.
NCT01319812 is a Phase 2 study that has completed, run by Biotronik. The registered enrollment target is 463 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (248% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01319812, a Phase 2 study, has completed, sponsored by Biotronik.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 463 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The primary effectiveness endpoint for the Pulsar stent group is the primary patency rate at 12 months post-index procedure. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of \> 50% stenosis.
Interventions
- DEVICE Astron Stents
- DEVICE Pulsar Stents
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 463 participants |
| Start Date | 2011-07 |
| Est. Completion | 2017-09-07 |
| Phase | Phase 2 |
What the finished NCT01319812 record still lists
NCT01319812 is an interventional study that assigns participants to a tested intervention. The registered 463 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (248% higher).
The record links to 0 conditions, and to 2 interventions - of which Astron Stents is the first listed.
NCT01319812 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01319812 about?
NCT01319812 is a clinical study titled "Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents". 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 ...
What is the current status of trial NCT01319812?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 463 participants. The study started on 2011-07. Estimated completion is 2017-09-07.
What interventions are being tested in trial NCT01319812?
The interventions under investigation include: Astron Stents (DEVICE), Pulsar Stents (DEVICE).
Who is sponsoring clinical trial NCT01319812?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01319812's enrollment target sits among peer trials
463 82nd of 2000 higher than 1,919 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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