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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 is a Phase 2 study that has completed, run by Biotronik. The registered enrollment target is 463 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01319812
The ClinicalTrials.gov registry entry for NCT01319812 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 463 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biotronik, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Astron Stents is the first listed.
NCT01319812 reports 0 study locations.
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.
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