Thrombogenicity Assessment in Patients Treated With Bioresorbable Vascular Scaffolds

Withdrawn before enrolling

Conditions studied: Coronary Artery Disease

In brief

Platelet activation and aggregation, intrinsic thrombogenicity, and biomarkers (fibrinogen, C-reactive protein, platelet endothelial cell adhesion molecule, von Willebrand factor, p-selectin) will be measured and compared following the implantation of Bioreabsorbable Vascular Scaffolds and Drug Eluting Stents.

Key facts

Study ID

NCT03033862

Run by

Inova Health Care Services

People needed

0

Starts

2017-07-01

Expected to finish

2017-07-01

Last updated by the study team

2020-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject may be of either sex and of any race, and must be >18 years of age.
• Subjects undergoing elective PCI due to de novo native coronary artery lesions (length ≤24 mm) with a reference vessel diameter of ≥2.5 mm and ≤3.75 mm.
• Subject agrees to not participate in any other investigational or invasive clinical study for a period of 3 months following the index procedure.
• Subject must be willing and able to give appropriate informed consent.
• The subject is able to read and has signed and dated the informed consent document including authorization permitting release of personal health information approved by the investigator's Institutional Review Board (IRB).

You may not qualify if…

• Hemodynamically unstable at the time of enrollment.
• Concurrent or anticipated treatment with warfarin (or derivatives, e.g., phenprocoumon), oral factor Xa inhibitor, or oral direct thrombin inhibitor after enrollment.
• GPI use prior to or at the time of PCI.
• History of a bleeding, or evidence of active abnormal bleeding.
• History at any time of intracranial hemorrhage, intracranial or spinal cord surgery, or a central nervous system tumor or aneurysm.
• Documented sustained severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) at enrollment.
• Severe valvular heart disease, as defined by the American College of Cardiology /American Heart Association.
• History within 30 days before enrollment of invasive surgeries (other than mentioned above), or is anticipating one during the course of their study participation, or is planning to have one within 1 month post dosing with the study drug.
• History within 30 days before enrollment of TIA and ischemic (presumed thrombotic) stroke/CVA.
• Known platelet count <100,000/mm3 within 30 days before enrollment.
• Known active hepatobiliary disease, or known unexplained persistent increase in serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) activity to two times or more the upper limit of the reference range (upper limit of "normal" [↑2xULN]).
• Any serious medical comorbidity (e.g., active malignancy) such that the subject's life expectancy is <24 months.
• Known current substance abuse at the time of enrollment.
• Current participation in any other study of investigational therapy or participation in such a study within the last 30 days.
• Known hypersensitivity to any component of the current investigational product.
• Female subject of child-bearing potential.
• Subject is a woman who is breast-feeding.
• Subject is part of the staff personnel directly involved with this study or is a family member of the investigational staff.
• LVEF <30%
• Subject with known renal insufficiency with an estimated GFR <30 ml/min/1.73m or dialysis at the time of screening
• Subject requiring at least two lesion treatment and more suitable for staged PCI.
• Moderate or heavy calcification, tortuosity or other conditions are present proximal or within the target segment, reducing the likelihood that the Absorb BVS or XIENCE can be either delivered to or expanded at the lesion.
• Extreme angulation (≥90°) proximal to or within the target lesion.
• Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
• Lesion located within or distal to a diseased arterial graft or SVG.

Where it is running

• Inova Fairfax Hospital — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.