Thrombogenicity Assessment in Patients Treated With Bioresorbable Vascular Scaffolds

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.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Bioresorbable Vascular Scaffold; Device: Drug Eluting Stent

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include subjects with stable ischemic heart disease receiving percutaneous coronary intervention.

Description

Inclusion Criteria:

1. Subject may be of either sex and of any race, and must be >18 years of age.
2. 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.
3. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 3 months following the index procedure.
4. Subject must be willing and able to give appropriate informed consent.
5. 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).

Exclusion Criteria:

• 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.
• Aorto-ostial lesion (within 3 mm of the aorta junction).
• Lesion located in the left main artery.
• Lesion located within 2 mm of the origin of the LAD or LCX.

• Lesion involving a bifurcation with a:

  • side branch ≥ 2 mm in diameter, or
  • side branch with either an ostial or non-ostial lesion with diameter stenosis > 50%, or
  • side branch requiring dilatation.
• Target vessel contains thrombus.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention with Bioresorbable Vascular Scaffold; Implant of Abbott Bioresorbable stent	Device: Bioresorbable Vascular Scaffold; Bioresorbable Vascular Scaffold
Intervention with Drug Eluting Stent; implant of drug eluting stent	Device: Drug Eluting Stent; Drug Eluting Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Thrombogenicity from baseline after device implantation	Platelet activation and aggregation, intrinsic thrombogenicity, and biomarkers will be measured at baseline and then reassessed at multiple time points after the implantation of the study device.	60 Days

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Investigators: Principal Investigator: Paul A Gurbel, MD, Inova Health Care Services

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 16-2565

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No