Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01612767 · ClinicalTrials.gov registry record · Phase 2
BIOHELIX-I Bare Metal Stent Study
A Phase 2 study, sponsored by Biotronik.
- Completed
- Registry status
- Phase 2
- Development phase
- 329
- Enrollment target
NCT01612767: Completed Phase 2 study, sponsored by Biotronik.
NCT01612767 is a Phase 2 study that has completed, run by Biotronik. The registered enrollment target is 329 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (147% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01612767, a Phase 2 study, has completed, sponsored by Biotronik.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 329 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the safety and efficacy of the investigational BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.
Primary Outcome
The primary endpoint for the Pro-Kinetic Energy Stent is the target vessel failure rate at 9-months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction and ischemia-driven target vessel revascularization.
Interventions
- DEVICE PRO-Kinetic Energy Stent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 329 participants |
| Start Date | 2012-11 |
| Est. Completion | 2017-11 |
| Phase | Phase 2 |
What the finished NCT01612767 record still lists
NCT01612767 is an interventional study that assigns participants to a tested intervention. The registered 329 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 (147% higher).
The record links to 0 conditions, and to 1 intervention - of which PRO-Kinetic Energy Stent is the first listed.
NCT01612767 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01612767 about?
NCT01612767 is a clinical study titled "BIOHELIX-I Bare Metal Stent Study". The purpose of this study is to demonstrate the safety and efficacy of the investigational BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.
What is the current status of trial NCT01612767?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 329 participants. The study started on 2012-11. Estimated completion is 2017-11.
What interventions are being tested in trial NCT01612767?
The interventions under investigation include: PRO-Kinetic Energy Stent (DEVICE).
Who is sponsoring clinical trial NCT01612767?
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 NCT01612767's enrollment target sits among peer trials
329 146th of 2000 higher than 1,855 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06036446 · 329 participants · NA
LATe Cerclage in High-risk Pregnancies (LATCH)
- NCT00359684 · 330 participants
Use of Cysteamine in the Treatment of Cystinosis
- NCT03817502 · 330 participants · Phase 3
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
- NCT03922724 · 330 participants · Phase 2
Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia