Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01602159 · ClinicalTrials.gov registry record · NA
Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
NCT01602159: Completed NA study, sponsored by Johns Hopkins University.
NCT01602159 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 29 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01602159, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
Study Summary
This is a prospective randomized controlled trial to compare clinical improvement, cost effectiveness and patency rates between new and improved Nitinol stents and open bypass surgery in the superficial femoral artery disease. Secondary outcomes also include comparing quality of life, re-intervention rate, mortality, morbidity and time to return to work or regular activities. Patients with superficial femoral artery lesions will be considered. Patients with TASC II A lesions will not be randomized but treated with PTA/stenting as standard of care. Patients with TASC II B and C lesions will be prospectively randomized into either receiving open bypass or stenting. Patients with TASC D lesions will be treated with open bypass surgery after angiography. The investigators will collect pre-procedure, peri-procedural and clinical follow-up data on all enrolled the patients.
Primary Outcome
Clinical Improvement is measured as at least 1 Rutherford category
Interventions
- PROCEDURE Open Bypass Surgery
- PROCEDURE Angioplasty and Stenting
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2009-07 |
| Est. Completion | 2014-06 |
| Phase | NA |
What the finished NCT01602159 record still lists
NCT01602159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Open Bypass Surgery is the first listed.
NCT01602159 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01602159 about?
NCT01602159 is a clinical study titled "Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)". This is a prospective randomized controlled trial to compare clinical improvement, cost effectiveness and patency rates between new and improved Nitinol stents and open bypass surgery in the superficial femoral artery disease. Secondary outcomes also include comparing quality of life, re-interventi...
What is the current status of trial NCT01602159?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2009-07. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01602159?
The interventions under investigation include: Open Bypass Surgery (PROCEDURE), Angioplasty and Stenting (PROCEDURE).
Who is sponsoring clinical trial NCT01602159?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01602159's enrollment target sits among peer trials
29 1702nd of 2000 higher than 297 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
- NCT02429557 · 29 participants · Phase 1
Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
- NCT02568878 · 29 participants · Phase 3
Creatine for Depressed Male and Female Methamphetamine Users
- NCT03014401 · 29 participants · NA
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
- NCT03128996 · 29 participants · Phase 1
Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders
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