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

This study has been completed.
Sponsor:
Information provided by:
Corindus Inc.
ClinicalTrials.gov Identifier:
NCT01076036
First received: February 24, 2010
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: CorPath 200
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CorPath™ 200 System: Coronary Remote Catheterization Feasibility Study

Resource links provided by NLM:


Further study details as provided by Corindus Inc.:

Primary Outcome Measures:
  • < 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) [ Time Frame: 48-hrs or hospital discharge, whichever occurs first ] [ Designated as safety issue: Yes ]
  • Successful CorPath-assisted navigation, deployment and retrieval of the PCI devices without in-hospital MACE [ Time Frame: 48-hrs or hospital discharge whichever occurs first ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • MACE [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • < 30% final diameter stenosis of the target lesion without MACE [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: February 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CorPath 200
    CorPath™ 200 robotically-assisted percutaneous coronary intervention
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076036

Locations
Colombia
CORBIC Cardio-Neuro-Vascular Institute
Medellin, Colombia
Sponsors and Collaborators
Corindus Inc.
Investigators
Principal Investigator: Juan F Granada, MD CORBIC and CRF
  More Information

No publications provided

Responsible Party: Michail M. Pankratov, Vice President, Clinical and Regulatory Affairs, Corindus
ClinicalTrials.gov Identifier: NCT01076036     History of Changes
Other Study ID Numbers: Corindus-Corbic-2010
Study First Received: February 24, 2010
Last Updated: January 10, 2011
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Corindus Inc.:
ischemia
stent

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

ClinicalTrials.gov processed this record on April 17, 2014