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NCT01330628 · ClinicalTrials.gov registry record · Phase 2
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
A Phase 2 study, sponsored by Spectranetics Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 252
- Enrollment target
NCT01330628: Completed Phase 2 study, sponsored by Spectranetics Corporation.
NCT01330628 is a Phase 2 study that has completed, run by Spectranetics Corporation. The registered enrollment target is 252 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01330628, a Phase 2 study, has completed, sponsored by Spectranetics Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 252 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
Primary Outcome
Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.
Interventions
- DEVICE Turbo Elite Laser and Turbo Tandem Laser Guide Catheters
- PROCEDURE Balloon angioplasty
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2011-06 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
What the finished NCT01330628 record still lists
NCT01330628 is an interventional study that assigns participants to a tested intervention. The registered 252 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 (89% higher).
The record links to 0 conditions, and to 2 interventions - of which Turbo Elite Laser and Turbo Tandem Laser Guide Catheters is the first listed.
NCT01330628 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01330628 about?
NCT01330628 is a clinical study titled "Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis". The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
What is the current status of trial NCT01330628?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 252 participants. The study started on 2011-06. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01330628?
The interventions under investigation include: Turbo Elite Laser and Turbo Tandem Laser Guide Catheters (DEVICE), Balloon angioplasty (PROCEDURE).
Who is sponsoring clinical trial NCT01330628?
This trial is sponsored by Spectranetics Corporation, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01330628's enrollment target sits among peer trials
252 220th of 2000 higher than 1,779 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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