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Thrombogenicity Assessment in Patients Treated With Bioresorbable Vascular Scaffolds | Clinical Trials | Clareo Health

WITHDRAWN

Thrombogenicity Assessment in Patients Treated With Bioresorbable Vascular Scaffolds

NCT03033862•Inova Health Care Services

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+23 more criteria

Locations (1)

Inova Fairfax Hospital

Falls Church, Virginia, United States

Key Dates

Start Date

July 1, 2017

Primary Completion Date

July 1, 2017

Completion Date

July 1, 2017

Last Updated

June 16, 2020

Conditions

Coronary Artery Disease

Interventions

Bioresorbable Vascular Scaffold

DEVICE

Drug Eluting Stent

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 16, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Thrombogenicity Assessment in Patients Treated With Bioresorbable Vascular Scaffolds

Inclusion Criteria

Exclusion Criteria

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