Peripheral Arterial Disease Clinical Trial
Official title:
A Prospective, Single-Arm Study to Evaluate the Effects of the Jetstream G3 System on Calcified Peripheral Vascular Lesions
Verified date | October 2015 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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 intravascular ultrasound (IVUS).
Status | Completed |
Enrollment | 55 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 100 Years |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | St. John Hopital | Detroit | Michigan |
United States | Mercy Medical Center | Knoxville | Tennessee |
United States | Wheaton Franciscan Healthcare | Milwaukee | Wisconsin |
United States | Arizona Heart Institute | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Luminal Area Change | lumen area change as measured by intravascular ultrasound (IVUS) | Day 0 | No |
Secondary | Adjunctive Therapy Use | Day 0 | No | |
Secondary | Residual Diameter Stenosis | lumen diameter stenosis change post-atherectomy | Day 0 | No |
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