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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01602159
The ClinicalTrials.gov registry entry for NCT01602159 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Open Bypass Surgery is the first listed.
NCT01602159 reports 0 study locations.
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.
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