Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)

Claudication Clinical Trial

— ROBUST  

Official title:

Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01602159
• Other study ID #: NA_00027939
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: June 2014

Study information

• Verified date: September 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Clinical Inclusion:

1. Must be at least 18 years of age.

2. Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site.

3. Symptomatic patient as evidence by IC or CLI.

4. Patient has failed maximized medical treatment and exercise program.

5. Patient has a resting ABI < 0.9 or an abnormal exercise ABI if resting ABI is normal.Patient with non-compressible arteries (ABI > 1.2) must have a TBI < 0.8.

6. Patient has a de novo or restenotic lesion(s) with > 50% stenosis documented angiographically.

7. Patient agrees to return for all required clinical contacts following study enrollment.

8. Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.

Anatomical Inclusion:

1. Patient with any SFA lesion

2. At least one tibial vessel runoff with < 50% stenosis

3. Lesion starts start at least 1 cm distal to the deep femoral artery

4. Lesion end at least 3 cm above the knee joint

5. Target vessel reference diameter is > 3 mm & < 6.5 mm

Exclusion Criteria:

Clinical exclusion:

1. Known allergic reaction to anesthesia not able to overcome by medication.

2. Known allergic reaction to contrast not able to overcome by medication.

3. Known history of intolerance to study medicating including ASA, clopidogrel, or ticlopidine.

4. Bleeding disorder or refuses blood transfusion.

5. Prior stenting or bypass of SFA (prior PTA is not an exclusion criteria)

6. Unstable angina, recent MI within a month

7. Malignancy or other condition limiting life expectancy to < 5 years.

8. Renal insufficiency (serum Cr > 2.0)

9. Patient has any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe (e.g., morbid obesity).

Anatomic Exclusion:

1. Lesion < 1 cm from origin of DFA

2. Lesion < 3 cm from the knee joint

3. Chronic total occlusion of SFA > 20cm.

4. Chronic total occlusion of CFA.

5. Proximal trifurcation occlusions.

Related Conditions & MeSH terms

• Claudication
• Intermittent Claudication
• Rest Pain
• Superficial Femoral Artery Occlusion
• Superficial Femoral Artery Stenosis

Intervention

Procedure:
• Open Bypass Surgery
Open Bypass Surgery with Autogenous vein or PTFE Graft
• Angioplasty and Stenting
Angioplasty and Stenting of the superficial Femoral artery with Nitinol stent (Life Stent flexStar Stent System by Bard Inc. Tempe AZ).

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement	Clinical Improvement is measured as at least 1 Rutherford category	12 Month Post Operatively
Primary	Patency rate	Primary, primary assisted and secondary at 6, 12 month	12 Month Post Operatively
Primary	Cost effectiveness	Cost Effectiveness factoring procedure and hospital admission costs	12 Month Post Operatively
Secondary	Quality of Life improvement	Improvement of quality of life measured using VQL	12 Month Post Operatively
Secondary	Re-intervention rate		12 Month Post Operatively
Secondary	Technical success of both treatment modalities		12 Month Post Operatively
Secondary	30-day operative mortality		12 Month Post Operatively
Secondary	Time to return to work and regular activities		12 Month Post Operatively
Secondary	Morbidity associated with both treatment modalities		12 Month Post Operatively

External Links

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