Ignite Creation Date:
2024-05-05 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 9:47 AM
Study NCT ID:
NCT00651885
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2008-03-31
Brief Title:
Safety Study of UT-15C SR Oral Treprostinil in Patients Undergoing a Lower Limb Endovascular Procedure
Sponsor:
Ochsner Health System
Organization:
Ochsner Health System
Study Overview
Official Title:
A Randomized Single-Center Placebo Controlled Study To Assess the Safety of UT-15C Treprostinil Diethanolamine Sustained Release SR in Patients Undergoing an Infra-Popliteal Endovascular Intervention for the Treatment of Critical Limb Ischemia
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 endovascular procedures such as percutaneous transluminal endovascular intervention as well as reconstructive surgical procedures such as grafts or bypasses Amputation is a last resort where limb salvage cannot be achieved Despite the success of percutaneous intervention for small coronary vessels with lumen diameters less than 3 mm similar techniques have had limited success in the lower extremity vessels Infra-popliteal or below the knee endovascular intervention is commonly plagued by subacute thrombotic closure and restenosis in as many as 50 of treated patients As a result of the limited success these percutaneous procedures have been reserved for the severest cases whereby limb loss is imminent without intervention In this context the sickest of all patients are enrolled in these trials and poor outcomes are common regardless of the intervention Agents that promote intracellular cAMP accumulation including prostacyclin analogues and phosphodiesterase inhibitors suppress smooth muscle proliferation promote vasodilatation and inhibit platelet aggregation These properties suggest that prostacyclin analogues such as treprostinil will be useful adjuncts to peripheral endovascular intervention and perhaps increase the number of patients with CLI that can benefit from peripheral endovascular intervention An orally available prostacyclin analogue could represent an important treatment advance in the prevention of restenosis following infrapopliteal angioplasty In the present study the safety and efficacy of oral UT-15C sustained release SR tablets will be compared to placebo in patients with CLI undergoing an infra-popliteal endovascular intervention
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 intervention procedure Conventional therapy should be continued for all patients in the study Conventional therapy is defined as the customary best medical practice at this investigative site for CLI including analgesics for rest pain debridement and wound care for ischemic wounds etc as long as such care meets the other requirements of the study and does not include prohibited therapies or investigational medications A total of 20 patients will be prospectively randomized 11 to conventional treatment and placebo therapy in conjunction with an endovascular procedure or conventional treatment and UT-15C SR therapy in conjunction with an infrapopliteal endovascular procedure Treatment is UT-15C sustained release SR tablets 10 mg dosage strength or placebo Treatment will be initiated at 1 mg twice daily with dose escalation of an additional 1 mg twice daily every 5 days if clinically indicated based upon the presence of known prostacyclin adverse events or adverse events that in the opinion of the investigator are attributable to UT-15C SR Doses should be maximized throughout the Treatment Phase up to a maximum dose of 5 mg twice daily at the end of 12-weeks Patients will return to the institution for the endovascular procedure at least 4 days after starting study drug and continue study drug throughout the endovascular procedure and to Week 12 All patients will return to the clinic at Weeks 2 6 and 12 for Treatment Phase assessments and then Weeks 26 and 52 for follow-up assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None