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View Clinical Trial (Medical Research Study)
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Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery - NCT00933270-02115 (Clinical Trial 300902)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy300902.aspx
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| City: |
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Boston |
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State:
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MA |
| Zip Code: |
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02115 |
| Conditions: |
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Peripheral Vascular Disease |
| Purpose: |
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The main objective of this study is to demonstrate the safety and effectiveness of the IDev
SUPERA® Nitinol Stent System in treating subjects with obstructive superficial femoral
artery (SFA) disease. The primary endpoint will be the primary patency of the SFA evaluated
at 12 months. The outcome will be compared to a performance goal based on clinical trials of
percutaneous transvenous angioplasty (PTA) alone.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
1. Age greater than or equal to 18 years and of age of legal consent.
2. Women of child bearing potential must have a negative pregnancy test within 7 days
prior to the index procedure.
3. Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale
2-4) with a resting ABI less than or equal to 0.9. TBI is performed if ABI is
inadequate.
4. A single superficial femoral artery lesion with greater than 60% stenosis or total
occlusion.
5. Stenotic lesion(s) or occluded length within the same vessel (one long or multiple
serial lesions) greater than or equal to 40 mm to less than or equal to 140 mm.
Reference vessel diameter (RVD) greater than or equal to 4.0 mm and less than or
equal to 6.0 mm by visual assessment.
6. All lesions are to be located with the distal point at least 3 cm above the knee
joint, defined as the distal end of the femur at the knee joint, and proximal point
at least 2 cm below the origin of the profunda artery.
7. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with
at least one of three vessels patent (less than 50% stenosis) to the ankle or foot.
8. The target lesion(s) can be successfully crossed with a guide wire and dilated.
9. Poor aortoiliac or common femoral "inflow" (i.e., angiographically defined greater
than 50% stenosis of the iliac or common femoral artery) that would be deemed
inadequate to support a femoropopliteal bypass graft must be successfully treated
prior to treatment of the target lesion. This can be done just prior to treatment of
the target lesion. Successful treatment is defined as less than 30% stenosis after
either PTA or stenting of the inflow lesion. After treatment of the inflow lesion,
the pressure gradient across the target lesion will be obtained and if the pressure
gradient is greater than or equal to 20 mmHg, then the subject will be included in
the study.
10. A subject with bilateral obstructive SFA disease is eligible for enrollment into the
study. If a subject with bilateral disease is enrolled, the target limb will be
selected at the Investigator's discretion, who may use the criteria of lesion length,
percent stenosis, and/or calcification content. The contra-lateral procedure should
not be done until at least 30 days after the index procedure (staged).
11. The subject is eligible for standard surgical repair, if necessary.
12. A subject who requires a coronary intervention should have it performed at least 7
days prior to the treatment of the target lesion.
13. Subject must provide written informed consent.
14. Subject must be willing to comply with the specified follow-up evaluation schedule.
Exclusion Criteria:
1. Thrombophlebitis or deep venous thrombus, within the previous 30 days.
2. Receiving dialysis or immunosuppressant therapy within the previous 30 days.
3. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where
complete resolution of the thrombus was not achieved.
4. Stroke within the previous 90 days.
5. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
6. Required stent placement via a popliteal approach.
7. Required stent placement across or within 0.5 cm of the SFA/PFA bifurcation.
8. Procedures which are pre-determined to require stent-in-stent placement to obtain
patency, such as in-stent restenosis.
9. Significant vessel tortuosity or other parameters prohibiting access to the lesion or
90° tortuosity which would prevent delivery of the stent device.
10. Required stent placement within 1 cm of a previously deployed stent.
11. Subject required a coronary intervention, and the coronary intervention was done less
than 7 days prior to or planned within 30 days after the treatment of the target
lesion.
12. Known allergies to any of the following: aspirin, clopidogrel bisulfate (Plavix®),
ticlopidine (Ticlid ®), heparin, nitinol (nickel titanium), or contrast agent, that
cannot be medically managed.
13. Presence of thrombus prior to crossing the lesion.
14. Known or suspected active infection at the time of the procedure.
15. Presence of an ipsilateral arterial artificial graft.
16. Use of cryoplasty, laser, or atherectomy devices at the time of index procedure.
17. Restenotic lesion that had previously been treated by atherectomy, laser or
cryoplasty within 3 months of the index procedure.
18. Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
19. History of neutropenia, coagulopathy, or thrombocytopenia.
20. Known bleeding or hypercoagulability disorder or significant anemia (Hb < 8.0) that
cannot be corrected.
21. Subject has the following laboratory values:
1. platelet count less than 80,000/μL,
2. international normalized ratio (INR) greater than 1.5,
3. serum creatinine level greater than 2.0 mg/dL.
22. Subject requires general anesthesia for the procedure.
23. Subject is pregnant or plans to become pregnant during the study.
24. Subject has a co-morbid illness that may result in a life expectancy of less than 1
year.
25. Subject is participating in an investigational study of a new drug, biologic or
device at the time of study screening. NOTE: Subjects who are participating in the
long term follow-up phase of a previously investigational and now FDA-approved
product are not excluded by this criterion. |
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| Study is available at: |
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Brigham and Women's Hospital
Boston, MA 02115
United States
Primary Contact:
Carol Base, RN, MS
Email: cbase@idevmd.com
Phone: 281-333-1998 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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