Status:
COMPLETED
Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular Procedure
Lead Sponsor:
Ochsner Health System
Collaborating Sponsors:
United Therapeutics
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In chronic CLI patients who are appropriate candidates for endovascular procedures - and many patients are not because of their advanced age and disease state - the treatment regimen may include endov...
Detailed Description
This study is a randomized, placebo controlled, single-center, evaluation of the safety and efficacy of UT-15C SR compared to placebo in patients with CLI with a planned infra-popliteal endovascular i...
Eligibility Criteria
Inclusion
- Be 18 or older.
- Have an anticipated infra-popliteal endovascular intervention.
- Have a diagnosis of stage IIb- IVa (Fontaine) or stage 3- 5 (Rutherford scale) CLI due to documented peripheral arterial disease (Appendix E)
- If female, be physiologically incapable of childbearing or practicing acceptable methods of birth control.
- Have signed an appropriate informed consent for participation in this study.
Exclusion
- Have had a previous endovascular intervention or stenting on the target limb.
- Be hemodynamically unstable, on hemodialysis for end stage renal failure, or have acute renal, cardiac or pulmonary failure.
- Have a history of intracranial bleeding, bleeding ulcer, urinary tract bleeding; or bleeding due to significant trauma within six weeks prior to study entry.
- Have a life-threatening malignancy requiring aggressive chemotherapy.
- Have any condition or laboratory value which, based on information in the UT-15C SR investigators' brochure, would constitute an unacceptable risk to the patient's safety, in the opinion of the investigator.
- Have unstable psychiatric status or be mentally incapable of understanding the objectives, nature or consequences of the trial.
- Have a known hypersensitivity to prostacyclin.
- Have participated in any investigational trial within 30 days of study drug initiation.
- Have been a non-responder to chronic (\>30 days) prostanoid treatment, or have completed a chronic trial of prostanoid therapy within 30 days of study drug initiation.
- Be a pregnant or nursing woman.
- \-
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00651885
Start Date
March 1 2008
End Date
December 1 2010
Last Update
April 24 2023
Active Locations (1)
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1
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121