Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-27 @ 6:58 PM
Study NCT ID:
NCT01602159
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2012-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROBUST
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: