Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/23/2018 |
| Start Date: | June 2013 |
| End Date: | July 2020 |
ILLUMENATE Pivotal: ProspectIve, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon
This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated
percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with
peripheral arterial disease.
percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with
peripheral arterial disease.
The ILLUMENATE Pivotal study is a prospective, randomized, multi-center, single-blind study
which will include up to 360 subjects in approximately forty-five (45) sites across the
United States to evaluate the CVI Paclitaxel-coated PTA Catheter compared to the bare
percutaneous transluminal angioplasty balloon catheter (bare balloon catheter) for the
treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for
in-stent) SFA and/or popliteal arteries.
which will include up to 360 subjects in approximately forty-five (45) sites across the
United States to evaluate the CVI Paclitaxel-coated PTA Catheter compared to the bare
percutaneous transluminal angioplasty balloon catheter (bare balloon catheter) for the
treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for
in-stent) SFA and/or popliteal arteries.
Inclusion Criteria:
- Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral
Artery (SFA) or popliteal artery.
Exclusion Criteria:
- Known intolerance to study medications, paclitaxel or contrast agents that in the
opinion of the investigator cannot be adequately pre-treated
We found this trial at
43
sites
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Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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Emory University Hospital As the largest health care system in Georgia and the only health...
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Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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