- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03033862
Thrombogenicity Assessment in Patients Treated With Bioresorbable Vascular Scaffolds
12. juni 2020 opdateret af: Inova Health Care Services
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.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Virginia
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Falls Church, Virginia, Forenede Stater, 22042
- Inova Fairfax Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The study will include subjects with stable ischemic heart disease receiving percutaneous coronary intervention.
Beskrivelse
Inclusion Criteria:
- 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).
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Intervention with Bioresorbable Vascular Scaffold
Implant of Abbott Bioresorbable stent
|
Bioresorbable Vascular Scaffold
|
Intervention with Drug Eluting Stent
implant of drug eluting stent
|
Drug Eluting Stent
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Thrombogenicity from baseline after device implantation
Tidsramme: 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.
|
60 Days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Paul A Gurbel, MD, Inova Health Care Services
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2017
Primær færdiggørelse (Faktiske)
1. juli 2017
Studieafslutning (Faktiske)
1. juli 2017
Datoer for studieregistrering
Først indsendt
6. januar 2017
Først indsendt, der opfyldte QC-kriterier
24. januar 2017
Først opslået (Skøn)
27. januar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juni 2020
Sidst verificeret
1. august 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 16-2565
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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