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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014