Phase
Condition
Organ Transplant
Occlusions
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is ≥ 18 years of age
Subject is scheduled for elective PCI, or unscheduled but non-emergent PCI, ordiagnostic catheterization with PCI if indicated. For non-elective cases, there mustbe at least two troponin levels within the upper limit of normal (ULN), at least 6hours apart prior to the index procedure
Subject is willing and capable of providing written informed consent
If the subject is a woman of childbearing potential, she must have had a negativepregnancy test within 24 hours of the study procedure
Exclusion
Exclusion Criteria:
Subject requires emergency PCI (i.e., PCI for evolving or ongoing STEMI/NSTEMI)
Subject has an elevated troponin level (cTnI or T) > ULN at baseline, based on labresults obtained from the treating institution
Subject is scheduled to undergo PCI with the use of Propofol
Subject has a recent history of drug treatment with potassium channel activators (e.g., Nicorandil) or potassium channel blockers (e.g., sulfonylureas) during the last 7 days prior to baseline
Subject had STEMI during the last 4 weeks prior to baseline. (Note: NSTEMI in the last 4 weeks prior to baseline is allowed if the baseline troponin is ≤ ULN.)
Underwent a CABG in the last 4 weeks prior to baseline
Had a PCI within the last 7 days prior to baseline
Subject has a life expectancy < 6 months
Subject has NYHA Class IV or decompensated heart failure
Subject has peripheral vascular disease requiring intervention during the indexhospitalization or within 4 weeks post-procedure
Subject has either serum creatinine >2 times the age-appropriate upper limit ofnormal, a glomerular filtration rate (GFR) of < 30 mL/min/1.73m2 or requires dialysis
Subject has systolic blood pressure > 200 mmHg
Subject is currently being treated with systemic oral or I.V. steroids
Subject has a known bleeding disorder or known abnormality of blood flow to the limbto be treated
Subject has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy orpre-existing traumatic injury to the limb to be treated
Subject is scheduled for a PCI procedure to treat a known Chronic Total Occlusion (CTO) lesion
Subject is currently participating in or is planning to participate in anotherinvestigational drug or device trial, prior to the 30-day follow-up visit. (Note:Observational studies or post-approval studies/ registries, are allowed.)
Planned (staged) post-index procedure intervention within 30 days (i.e., PCI ofnon-target lesions in any vessel or CABG). (Note: Planned revascularization (PCI orbypass) of a non-target lesion >30 days following the index procedure is allowed.)
Any cardiac surgical procedure planned within 30 days post-enrollment
Study Design
Study Description
Connect with a study center
William Osler Health System
Brampton, Ontario L6R 3J7
CanadaActive - Recruiting
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaActive - Recruiting
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesActive - Recruiting
Danbury Hospital
Danbury, Connecticut 06810
United StatesActive - Recruiting
University of Florida Health Jacksonville
Jacksonville, Florida 32209
United StatesActive - Recruiting
Iowa Heart Center
Des Moines, Iowa 50314
United StatesActive - Recruiting
Henry Ford Hospital
Detroit, Michigan 48202
United StatesActive - Recruiting
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
United StatesActive - Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111
United StatesActive - Recruiting
Southside Hospital
Bay Shore, New York 11706
United StatesActive - Recruiting
North Shore University Hospital
Manhasset, New York 11030
United StatesActive - Recruiting
Lenox Hill Hospital
New York, New York 10075
United StatesActive - Recruiting
Mount Sinai Hospital
New York, New York 10029
United StatesActive - Recruiting
Staten Island University Hospital
Staten Island, New York 10305
United StatesActive - Recruiting
Novant Health Heart and Vascular Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
NC Heart and Vascular Research
Raleigh, North Carolina 27607
United StatesActive - Recruiting

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