- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02477579
A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
14. august 2017 opdateret af: Nitiloop Ltd.
A Prospective, Multi-Center, Non-randomized, Single Arm, Open Label, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
This study evaluates the safety and effectiveness of the a novel device called NovaCross to help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries.
The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
145
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Central Arkansas Veterans Healthcare System
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Illinois
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Naperville, Illinois, Forenede Stater, 60540
- Edward Hospital
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New York
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New York, New York, Forenede Stater, 10032
- Columbia University Medical Center/New York Presbyterian Hospital
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Pennsylvania
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York, Pennsylvania, Forenede Stater, 17403
- York Hospital
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Krakow, Polen
- SPZOZ University Hospital in Krakow
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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 til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Adult aged 25-80
- Patient understands and has signed the study informed consent form.
- Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration) showing distal TIMI flow 0.
- Suitable candidate for non-emergent, coronary angioplasty
- Documented coronary angiography preceding the PCI reveals at least one CTO lesion situated in a non-infarct related coronary artery or its side branches
- Body Mass Index (BMI) < 40
- Left ventricle ejection fraction > 25%
Exclusion Criteria:
- Patient unable to give informed consent.
- Current participation in another study with any investigational drug or device.
- Patient is known or suspected not to tolerate the contrast agent.
- Aorta-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO, in-stent CTO.
- Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor).
- Appearance of a fresh thrombus or intraluminal filling defects.
- Recent major cerebrovascular event (history of stroke or TIA within 1 month)
- Cardiac intervention within 4 weeks of the procedure
- Renal insufficiency (serum creatinine of > 2.3mg/dl or 203μmol/L)
- Active gastrointestinal bleeding
- Active infection or fever that may be due to infection
- Life expectancy < 2 years due to other illnesses
- Significant anemia (hemoglobin < 8.0 mg / dl)
- Severe uncontrolled systemic hypertension (> 240 mmHg within 1 month of procedure)
- Severe electrolyte imbalance
- Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV.
- Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
- Recent myocardial infarction (MI) (within the past two weeks)
- Uncontrolled diabetes >2 serum glucose concentrations of >350 mg/dl within 7 days.
- Unwillingness or inability to comply with any protocol requirements
- Pregnant or nursing
- Extensive prior dissection from a coronary guidewire use
- Drug abuse or alcoholism.
- Patients under custodial care.
- Bleeding diathesis or coagulation disorder;
- Kawasaki's disease or other vasculitis
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: NovaCross
NovaCross microcatheter will be used.
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The NovaCross™ is a guidewire positioning and support microcatheter for improving chronic total occlusion (CTO) crossability.
The NovaCross™ gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extendable segment, both at its distal tip.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
MACE
Tidsramme: 30 days
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30 day MACE, defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).
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30 days
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Intra-procedural technical success
Tidsramme: Intra-procedure
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Intra-procedural technical success, defined as the ability of the NovaCross™ micro-catheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion (CTO) in the true vessel lumen.
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Intra-procedure
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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1. The ability to cross the lesion with a guidewire in the true lumen, effectively dilate the CTO lesion, and place a coronary stent with residual lumen stenosis of less than 30% while restoring antegrade TIMI 3 flow.
Tidsramme: Procedure
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1.
The ability to cross the lesion with a guidewire in the true lumen, effectively dilate the CTO lesion, and place a coronary stent with residual lumen stenosis of less than 30% while restoring antegrade TIMI 3 flow.
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Procedure
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Proximal cap (ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.)
Tidsramme: Procedure
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2. The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.
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Procedure
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Effectiveness of extendable portion (effectiveness of the extendable portion in intra-CTO microcatheter crossability)
Tidsramme: Procedure
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3. The effectiveness of the extendable portion in intra-CTO microcatheter crossability.
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Procedure
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Visualization (ability to have full visualization of the NovaCross during the CTO procedure)
Tidsramme: Procedure
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4. The ability to have full visualization of the NovaCross during the CTO procedure.
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Procedure
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Usability (Assess the usability of the NovaCross™ by the operator)
Tidsramme: Procedure
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5. Assess the usability of the NovaCross™ by the operator.
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Procedure
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Device-related perforation (at the site of target coronary lesion and/or its proximal reference segment)
Tidsramme: Procedure
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6. Device-related perforation at the site of target coronary lesion and/or its proximal reference segment.
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Procedure
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Simon Walsh, MD, Belfast Health and Social Care Trust
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)
17. maj 2015
Primær færdiggørelse (Faktiske)
10. august 2017
Studieafslutning (Faktiske)
10. august 2017
Datoer for studieregistrering
Først indsendt
17. juni 2015
Først indsendt, der opfyldte QC-kriterier
22. juni 2015
Først opslået (Skøn)
23. juni 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- NT-CLP-01
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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produkt fremstillet i og eksporteret fra U.S.A.
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Kliniske forsøg med Kronisk total okklusion af koronararterie
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