Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

CorPath™ 200: Robotically-Assisted Percutaneous Coronary Intervention (PCI)

6 agosto 2015 aggiornato da: Corindus Inc.

CorPath™ 200 System: Coronary Remote Catheterization Feasibility Study

An open-label, prospective, single-arm study is designed to evaluate safety, clinical and technical efficacy of the CorPath 200 System in delivery and manipulation of the coronary guide wires and balloon/stent systems for use in robotically-assisted, percutaneous coronary intervention (PCI) procedures.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Objective The study objective was to evaluate the safety and technical efficacy of the CorPath 200 System in delivery and manipulation of commercially available coronary guidewires and rapid exchange balloon/stent catheter for use in percutaneous coronary interventions (PCI).

I. Primary Endpoints A. Efficacy Device Clinical Success: Achievement of a < 30% final diameter stenosis after utilizing the CorPathTM 200 System to deliver a PTCA balloon and then stent to the target lesion, and successfully retract the devices without the occurrence of any In-Hospital MACE (Major Adverse Cardiac Event) evaluated at 48 hours post procedure or hospital discharge, whichever occurs first.

B. Safety In-Hospital MACE: Defined as the composite of death (all cause mortality), recurrent MI, and target vessel revascularization (emergent coronary artery bypass surgery [CABG] or PCI) evaluated at 48 hours post procedure or hospital discharge, whichever occurs first.

II. Secondary Endpoints A. Efficacy CorPath Success: Ability to navigate the guide wire and balloon/stent system utilizing the CorPath™ device to the target site without the occurrence of any In-Hospital MACE, evaluated at 48 hours post index procedure or hospital discharge, whichever occurs first.

Subject Clinical Success: Achievement of a <30% final diameter stenosis of target lesion after treatment with PTCA/coronary stent without the occurrence of any In-Hospital MACE, evaluated at 48 hours post-index procedure or hospital discharge, whichever occurs first.

B. Safety:

MACE at 30 Days: Defined as the composite of death, recurrent MI and/or target vessel revascularization (emergent coronary artery bypass surgery [CABG] or PCI) evaluated at 30 days post index procedure.

Adverse Events:

A summary of all adverse events observed in the trial summarized as either serious or non-serious and summarized by attribution.

C. Clinical Utility

Procedure Attributes:

  • Reduction in radiation exposure to the primary operator based on radiation dosimetry measurements at the procedure table and on a primary operator.
  • Total Procedure time based on the time of insertion of hemostasis sheath through the time of final guide catheter withdrawal.

CorPath Device Attributes:

Subjective assessment by the operator of the following device performance attributes:

  • Movement of the guide wire (rotating and advancing) to the target.
  • Maneuvering and position of the guide wire to the target.
  • Movement of the stent/balloon (advancing) to the target.
  • Ability to deliver the PTCA/stent system to the intended target lesion.
  • Ease of use of the system by the interventional team.

Material & Methods Corindus obtained approval (from the CORBIC Ethics Committee and INVIMA - Colombian Ministry of Health) in 2009 to conduct the clinical study "CorPath™ 200 System: Coronary Remote Catheterization Feasibility Study" at CORBIC Cardio-Neuro-Vascular Institute, Envigado, Colombia.

The study is a single arm, open label, prospective registry to treat a de novo lesion (2.5 mm - 4.0 mm in diameter, 25.0 mm in length with >50% stenosis) utilizing the CorPath 200 System to deliver, manipulate and retrieve a guidewire and a balloon/stent catheter system.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

8

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Colombia
      • Medellin, Colombia
        • CORBIC Cardio-Neuro-Vascular Institute

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

General Inclusion Criteria:

  • The subject is an acceptable candidate for PCI.
  • The subject must have clinical evidence of ischemic heart disease or a positive functional study.
  • Female subjects must be of non-child bearing potential, or if able to bear children, have a negative pregnancy test within seven (7) days prior to index procedure.
  • The subject or the legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.

Angiographic Inclusion Criteria:

  • Study lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated)
  • The study lesion is intended to be treated with one stent. Maximum stent length allowed is 20 mm.
  • The study reference vessel diameter is between 2.50 mm and 4.5 mm by visual estimate.
  • Study lesion diameter showing significant stenosis of at least 50% by visual estimate.

General Exclusion Criteria:

  • Subject requires planned PCI or CABG within 30 days following the index procedure.
  • Subject has evolving ST elevation myocardial infarction (STEMI) (i.e., beginning of MI symptoms within 72 hours prior to the planned index procedure).
  • Subject has documented left ventricular ejection fraction < 30%.
  • Subject has known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, stainless steel, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
  • Subject has a platelet count < 100,000 cell/mm3 or > 700,000 cell/ mm3, a WBC of < 3000 cell/ mm3 (e.g. thrombocytopenia, thrombocythemia, neutropenia or leucopenia).
  • Subject has a history of a stroke (CVA) or TIA within 30-days prior to planned index procedure.
  • Subject has an active peptic ulcer or upper GI bleeding within the 6 months prior to planned index procedure.
  • Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Subject is currently participating in another investigational drug l drug or device trial that has not completed the entire follow up period.

Angiographic Exclusion Criteria:

  • Study lesion that cannot be fully covered by a single stent of maximal length
  • Subject requires treatment of multiple lesions in the study vessel at the time of index procedure.
  • The study lesion requires planned treatment with DCA, laser, rotational atherectomy, or any device except for balloon dilatation prior to stent placement.
  • The study vessel has evidence of intraluminal thrombus or moderate to severe tortuosity (> 90o) proximal to the target lesion.

  • The study lesion has any of the following characteristics:

    1. Total occlusion
    2. Ostial location
    3. Involves a side branch > 2.0 mm vessel diameter
    4. Is located at >45° bend in the vessel
    5. Is moderately to severely calcified
    6. Moderate-to-severe calcification at the part of the vessel prior to target lesion
  • Unprotected left main coronary artery disease (an obstruction greater than 50% diameter stenosis in the left main coronary artery).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: CorPath 200 System
Robotic-assisted PCI with the CorPath 200
Dispositivo: CorPath 200
CorPath™ 200 robotically-assisted percutaneous coronary intervention
Dispositivo: CorPath 200
CorPath PCI - robotic-assisted percutaneous coronary intervention

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Clinical Procedural Success
Lasso di tempo: 48-hrs or hospital discharge, whichever occurs first
The percentage of Participants with <30% final diameter stenosis of the target lesion without in-hospital major adverse cardiovascular events (MACE) (defined as the composite of death, recurrent MI, and target vessel revascularization)
48-hrs or hospital discharge, whichever occurs first
Procedural Technical Success
Lasso di tempo: Intervention
Successful robotic delivery and retraction of all PCI devices during CorPath PCI procedure.
Intervention

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Corindus Inc.

Investigatori

  • Investigatore principale: Juan F Granada, MD, CORBIC and CRF

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2010

Completamento primario (Effettivo)

1 maggio 2010

Completamento dello studio (Effettivo)

1 maggio 2010

Date di iscrizione allo studio

Primo inviato

24 febbraio 2010

Primo inviato che soddisfa i criteri di controllo qualità

24 febbraio 2010

Primo Inserito (Stima)

25 febbraio 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

7 settembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 agosto 2015

Ultimo verificato

1 agosto 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Corindus-Corbic-2010

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Disfunsione dell'arteria coronaria

Prove cliniche su CorPath 200

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Trinidad & Tobago

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi