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NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions

20. März 2014 aktualisiert von: Boston Scientific Corporation

NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting Platinum Chromium Coronary Stent System (NG PROMUS Stent System) for the Treatment of Atherosclerotic Lesion(s)

NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting Platinum Chromium Coronary Stent System (NG PROMUS Stent System) for the Treatment of Atherosclerotic Lesion(s)

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

To evaluate clinical and peri-procedural angiographic and intravascular ultrasound (IVUS) outcomes for the NG PROMUS Everolimus-Eluting Platinum Chromium Coronary Stent System (NG PROMUS Stent System) in the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥ 2.50 mm to ≤ 4.0 mm in diameter (by visual estimate)

Studientyp

Interventionell

Einschreibung (Tatsächlich)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Australien
    • Western Australia
      • Fremantle, Western Australia, Australien, 6160
        • Fremantle Hospital
  • Neuseeland
      • Auckland, Neuseeland, 1010
        • Auckland City Hospital
      • Auckland, Neuseeland, 1003
        • Mercy Angiography Unit, Ltd. Mercy Hospital
      • Auckland, Neuseeland, 1030
        • North Shore Hospital
      • Auckland, Neuseeland, 1546
        • Ascot Angiography
      • Christchurch, Neuseeland, 8140
        • Christchurch
      • Otahuhu, Neuseeland, 1640
        • Middlemore Hospital
  • Singapur
      • Singapore, Singapur, 119228
        • National University Hospital Singapore
      • Singapore, Singapur, 168752
        • National Heart Center Singapore

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Clinical Inclusion Criteria:

  1. Subject must be at least 18 years of age
  2. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
  3. Subject is eligible for percutaneous coronary intervention (PCI)
  4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
  5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
  6. Subject is willing to comply with all protocol-required follow-up evaluation

Angiographic Inclusion Criteria:

  1. Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.50 mm and ≤4.0 mm
  2. Target lesion(s) length must be ≤34 mm (by visual estimate)
  3. Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following (stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress test or imaging stress test, or elevated biomarkers) prior to procedure
  4. Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
  5. The first lesion treated must be successfully pre-dilated/pretreated Note: Successful pre-dilatation/pretreatment refers to dilatation with a balloon catheter of appropriate length and diameter, or pretreatment with directional or rotational coronary atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.

Clinical Exclusion Criteria:

  1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
  2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
  3. Subject has received an organ transplant or is on a waiting list for an organ transplant
  4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
  5. Planned PCI (including staged procedures) or CABG after the index procedure
  6. Subject previously treated at any time with intravascular brachytherapy
  7. Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
  8. Subject has one of the following (as assessed prior to the index procedure):Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months; Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.);Planned procedure that may cause non-compliance with the protocol or confound data interpretation
  9. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome
  10. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
  11. Subject has a white blood cell (WBC) count < 3,000 cells/mm3
  12. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
  13. Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
  14. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  15. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
  16. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
  17. Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the time of the index procedure
  18. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
  19. Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
  20. Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
  21. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)

Angiographic Exclusion Criteria:

  1. Planned treatment of more than 3 lesions.
  2. Planned treatment of lesions in more than 2 major epicardial vessels
  3. Planned treatment of a single lesion with more than 1 stent
  4. Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
  5. Target lesion(s) is located in the left main
  6. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate.
  7. Target lesion(s) is located within a saphenous vein graft or an arterial graft
  8. Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
  9. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
  10. Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
  11. Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
  12. Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
  13. Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
  14. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: NG PROMUS stent
Single-arm treatment group receiving interventional NG PROMUS study stent
Gerät: Percutaneous coronary intervention (NG PROMUS)
Interventional coronary artery stenting with NG PROMUS study stent.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Technical Success Rate
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Technical success is defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician
Participants will be followed for the duration of hospital stay, an expected average of 1 day

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Target Lesion Revascularization (TLR) Rate
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is >/= 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:

  • The subject has a positive functional study corresponding to the area served by the target lesion.
  • The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.
  • The subject has ischemic symptoms referable to the target lesion. A TLR will be considered as ischemia-driven if the lesion diameter stenosis is >/= 70% by QCA even in the absence of clinical or functional ischemia.
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Target Lesion Failure (TLF) Rate
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non-Q-wave) related to the target vessel, or (cardiac) death. For the purposes of this protocol, if it cannot be determined with certainty whether the MI was related to the target vessel, it will be considered a TLF.

The MI definition used for Target Lesion Failure was the PLATINUM MI definition.
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Target Vessel Revascularization (TVR) Rate
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

Target vessel revascularization is defined as a TLR or a TVR remote. Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis >/= 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is >/= 50% by QCA and any of the following are present:

  • The subject has a positive functional study corresponding to the area served by the target vessel.
  • The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.
  • The subject has ischemic symptoms referable to the target vessel. A TVR will also be considered as ischemia-driven if the lesion diameter stenosis is >/=70% even in the absence of clinical or functional ischemia.
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Target Vessel Failure (TVF) Rate
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.

The MI definition used was the PLATINUM MI definition.
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
MI will be defined according to the PLATINUM Definition of MI with evidence pre-specified for i) Spontaneous, ii) PCI-related, iii) CABG related, and iv) autopsy evidence criteria.
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Cardiac Death Rate
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

Cardiac death is defined as death due to any of the following.

  • Acute MI
  • Cardiac perforation/pericardial tamponade
  • Arrhythmia or conduction abnormality
  • CVA through hospital discharge or CVA suspected of being related to the procedure
  • Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
  • Any death in which a cardiac cause cannot be excluded
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Non-cardiac Death Rate
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

Non-cardiac death is defined as a death not due to any of the following:

  • Acute MI
  • Cardiac perforation/pericardial tamponade
  • Arrhythmia or conduction abnormality
  • CVA through hospital discharge or CVA suspected of being related to the procedure
  • Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
  • Any death in which a cardiac cause cannot be excluded
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
All Death Rate
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Death is categorized as cardiac or non-cardiac deaths.
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Cardiac Death or MI Rate
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

Any cardiac death or MI event meeting the criteria defined for a cardiac death or MI.

MI definition used was the PLATINUM definition for MI.
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
All Death or MI Rate
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

Any all-cause mortality event or MI meeting the criteria defined for any death or MI.

MI definition used was the PLATINUM definition for MI.
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
All Death/MI/TVR Rate
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

Any event meeting the pre-specified criteria for any death, MI, or TVR.

MI definition used was the PLATINUM definition for MI.
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guide catheter has been removed and the patient left the catheterization lab.

Timing:

  • Acute stent thrombosis*: 0 24 hours after stent implantation
  • Subacute stent thrombosis*: >24 hours to 30 days after stent implantation
  • Late stent thrombosis: >30 days to 1 year after stent implantation
  • Very late stent thrombosis: >1 year after stent implantation * Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis is 0 30 days.

Stent thrombosis may be defined as:

  • Confirmed/definite
  • Probable
  • Possible

Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed)
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Clinical Procedural Success Rate
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day

Clinical procedural success is post-procedure diameter stenosis <30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death.

MI definition used was the PLATINUM definition for MI.
Participants will be followed for the duration of hospital stay, an expected average of 1 day
In-stent Percent Diameter Stenosis (%DS)
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day

As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-stent region.

Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100.
Participants will be followed for the duration of hospital stay, an expected average of 1 day
In-segment Percent Diameter Stenosis (%DS)
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day

As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-segment region (in-segment includes the stented region and 5 mm edge regions).

Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100.
Participants will be followed for the duration of hospital stay, an expected average of 1 day
In-stent Minimum Lumen Diameter (MLD)
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day

As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-stent region.

The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.
Participants will be followed for the duration of hospital stay, an expected average of 1 day
In-segment Minimum Lumen Diameter (MLD)
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day

As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-segment region (in-segment includes the stented region and 5 mm edge regions).

The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Acute Gain
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Acute gain, as measured by angiographic core lab
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Vessel Area
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day
As measured by IVUS, the mean vessel area (mm2).
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Stent Area
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day
As measured by IVUS, the area of the stent.
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Lumen Area
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day
As measured by IVUS, the area of the lumen.
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Vessel Volume
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day
As measured by IVUS, the volume of the vessel.
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Stent Volume
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day
As measured by IVUS, the volume of the stent.
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Lumen Volume
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day
As measured by IVUS, the volume of the lumen.
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Incomplete Apposition
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day

Incomplete apposition rate, as measured by the IVUS core lab.

Binary assessment of presence of one or more stent struts separated from the vessel wall as detected through intravascular ultrasound (IVUS).
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Percent Net Volume Obstruction
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day
The percentage of volume obstruction, as measured by the IVUS core lab.
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Longitudinal Stent Deformation
Zeitfenster: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Longitudinal stent deformation, evidenced by longitudinal compression or elongation, as the result of crossing a newly deployed stent with a second device, (such as a balloon catheter, stent system or IVUS catheter), causing the second device to become caught on the stent when the second device is advanced or retracted.
Participants will be followed for the duration of hospital stay, an expected average of 1 day

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Boston Scientific Corporation

Ermittler

  • Hauptermittler: John A Ormiston, MBChB, FRACP, FRACR, Mercy Angiography Unit, Ltd. Mercy Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2012

Primärer Abschluss (Tatsächlich)

1. März 2013

Studienabschluss (Tatsächlich)

1. März 2013

Studienanmeldedaten

Zuerst eingereicht

5. Oktober 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Oktober 2012

Zuerst gepostet (Schätzen)

10. Oktober 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

15. April 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. März 2014

Zuletzt verifiziert

1. März 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NG PROMUS Clinical Trial S2294

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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