View Clinical Trial (Medical Research Study)
A Prospective, Single-Arm Study to Evaluate the Effects of the Jetstream G3 System on Calcified Peripheral Vascular Lesions
| City: |
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Knoxville |
| State: |
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Tennessee |
| Zip Code: |
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37934 |
| Conditions: |
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Peripheral Arterial Disease |
| Purpose: |
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To investigate the treatment effects with the Jetstream G3 System in moderate to severely
calcified peripheral artery disease in the common femoral, superficial femoral or popliteal
arteries using IVUS.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
1. The patient is ≥ 18 years of age.
2. Patient has claudication determined to be due to femoropopliteal lesion(s) requiring
revascularization.
3. The target lesion(s) is/are located in the common femoral, superficial femoral or
popliteal arteries.
4. The reference vessel lumen (proximal to target lesion) is ≥ 3.0mm.
5. The patient is an acceptable candidate for percutaneous intervention using the
Jetstream G3 System in accordance with its labeled indications and instructions for
use.
6. The patient has signed approved informed consent.
7. Moderate or severe vessel obstructive intraluminal calcification as demonstrated by
IVUS and angiography.
Exclusion Criteria:
1. Patient has an uncontrollable allergy to nitinol, stainless steel or other stent
materials or to contrast agent.
2. Patient is unable to take appropriate anti-platelet therapy.
3. Patient has no distal runoff vessels.
4. Deep wall calcium.
5. Interventional treatment is intended for in-stent restenosis at the peripheral
vascular site.
6. Patient has target vessel with moderate or severe angulation (e.g., >30 degrees) or
tortuosity at the treatment segment.
7. Patient has a history of coagulopathy or hypercoagulable bleeding disorder.
8. Patient is receiving hemodialysis or has impaired renal function (creatinine is > 2.5
mg/dl) at the time of treatment.
9. Patient has evidence of intracranial or gastrointestinal bleeding within the past 3
months.
10. Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal
organ within the past 14 days.
11. Patient is pregnant or nursing a child.
12. Intended interventional treatment includes planned laser, brachytherapy or
atherectomy procedure other than the Jetstream G3 System.
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| NCT ID: |
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NCT01273623 |
| Primary Contact: |
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Principal Investigator
William Gray, MD
Center for Interventional Vascular Therapy-Columbia Medical
William Gray, MD
Phone: 212.342.0947
Email: wgray@crf.org
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| Backup Contact: |
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Email: petersk@pathwaymedical.com
Kevin P Peters
Phone: 206-790-9303
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| Location Contact: |
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Knoxville, Tennessee 37934
United States
Beth Polk, RN, CCRC
Phone: 865-218-7535
Email: bapolk@mercy.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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