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Thrombogenicity Assessment in Patients Treated With Bioresorbable Vascular Scaffolds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033862
Recruitment Status : Withdrawn (Stent taken off market due to safety concerns)
First Posted : January 27, 2017
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: Bioresorbable Vascular Scaffold Device: Drug Eluting Stent

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thrombogenicity Assessment in Patients Treated With Bioresorbable Vascular Scaffolds
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017

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




Primary Outcome Measures :
  1. Change in Thrombogenicity from baseline after device implantation [ Time Frame: 60 Days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will include subjects with stable ischemic heart disease receiving percutaneous coronary intervention.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033862


Locations
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United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Inova Health Care Services
Investigators
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Principal Investigator: Paul A Gurbel, MD Inova Health System
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Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT03033862    
Other Study ID Numbers: 16-2565
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: August 2018

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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
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases