Thrombogenicity Assessment in Patients Treated With Bioresorbable Vascular Scaffolds

NCT03033862 | Withdrawn FDA Device

• 1 other identifier: 16-2565
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention with Bioresorbable Vascular Scaffold

Implant of Abbott Bioresorbable stent

Device: Bioresorbable Vascular Scaffold

Intervention with Drug Eluting Stent

implant of drug eluting stent

Device: Drug Eluting Stent

Interventions

Bioresorbable Vascular Scaffold DEVICE

Bioresorbable Vascular Scaffold

Intervention with Bioresorbable Vascular Scaffold

Drug Eluting Stent DEVICE

Drug Eluting Stent

Intervention with Drug Eluting Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Paul A Gurbel, MD

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 27, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: June 16, 2020

Record last verified: 2018-08

Locations

US (1)