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Evaluation of the Safety and Effectiveness of the CorPath 200 System in Percutaneous Coronary Interventions (PCI) (PRECISE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corindus Inc.
ClinicalTrials.gov Identifier:
NCT01275092
First received: January 7, 2011
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

The objective of this study is to evaluate the safety and effectiveness of the clinical and technical performance of the CorPath® 200 System in the delivery and manipulation of coronary guidewires and stent/balloon systems for use in percutaneous coronary interventions (PCI).


Condition Intervention Phase
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Device: CorPath robotic-assisted PCI
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CorPath® PRECISE Percutaneous Robotically-Enhanced Coronary Intervention Study (PRECISE)

Resource links provided by NLM:


Further study details as provided by Corindus Inc.:

Primary Outcome Measures:
  • Percentage of Participants With Clinical Procedural Success [ Time Frame: 48-hrs or hospital discharge, whichever occurs first ] [ Designated as safety issue: Yes ]
    Defined as <30% residual stenosis in CorPath 200 System treated lesions at the completion of the interventional procedure (including stent placement) in the absence of MACE, either within 48 hours of the procedure or prior to hospital discharge, whichever occurs first.

  • Percentage of Patients With Device Technical Success [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    Defined as the successful advancement and retraction of PCI devices using the CorPath 200 System and without conversion to manual operation.


Secondary Outcome Measures:
  • The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    Defined as the difference between the radiation exposure measured at the procedure table (the conventional site of the primary operator) and the radiation exposure measured at the primary operator's position during the procedure. The radiation unit that was used was in milligray, but the measure is being reported as the ratio.


Enrollment: 164
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CorPath robotic-assisted PCI
CorPath 200 robotic-assisted PCI
Device: CorPath robotic-assisted PCI
CorPath 200® robotic-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:

  1. Subject is between 18 and 99 years of age.
  2. Subject is an acceptable candidate for PCI.
  3. Subject must have clinical evidence of ischemic heart disease or a positive functional study.
  4. Female subjects must be of non-child bearing potential, or if able to bear children, have a negative pregnancy test within 7 days prior to the CorPath procedure.
  5. 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:

  1. Study lesion is a single de novo native coronary artery lesion. This lesion may consist of multiple lesions (with 10mm or less between diseased segments) and must be completely covered by a single stent with at least 2.0mm of normal segments on proximal and distal edges of the lesion.
  2. Study reference vessel diameter is between 2.5mm and 4.0mm by visual estimate.
  3. Study lesion length is less than or equal to 24.0mm by visual estimate.
  4. Study lesion diameter showing stenosis of at least 50% by visual estimate.

General Exclusion Criteria:

  1. Subject requires planned PCI or CABG (Coronary Artery Bypass Graft) within 30 days following the CorPath procedure.
  2. Evidence of an acute myocardial infarction within 72 hours prior to the intended CorPath procedure.
  3. Subject has documented left ventricular ejection fraction <30%.
  4. Subject has undergone PCI within 72 hours prior to the CorPath procedure.
  5. Subject has undergone PCI within 30 days prior to the CorPath procedure and experienced a major adverse coronary event (MACE) or a serious adverse event (SAE) as defined in the protocol.
  6. Subject has known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, prasugrel, stainless steel, cobalt chromium, or sensitivity to contrast media, including Visipaque™, which cannot be adequately pre-medicated or managed with clinically appropriate substitutes.
  7. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, or a WBC (white blood cell) count of <3,000 cells/mm3 (e.g. thrombocytopenia, thrombocythemia, neutropenia or leukopenia).
  8. Subject has a serum creatinine level of >2.0 mg/dL or eGFR (estimated Glomerular Filtration Rate) <30 ml/min as measured within 7 days prior to the procedure.
  9. Subject has suffered a stroke within 30 days prior to planned CorPath procedure.
  10. Subject has an active peptic ulcer or upper gastrointestinal bleeding within the 6 months prior to planned CorPath procedure.
  11. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  12. Subject is currently participating in another investigational drug or drug/device or device trial and has not completed the entire follow up period.
  13. Femoral access is not possible.

Angiographic Exclusion Criteria:

  1. Target lesion that cannot be fully covered by a single stent.
  2. Subject requires treatment of more than one vessel.
  3. Any previous stent placement within 5.0 mm (proximal or distal) of the target lesion.
  4. The study lesion requires planned treatment with directional coronary atherectomy (DCA), laser, rotational atherectomy or any device except for balloon dilatation prior to stent placement.
  5. The study vessel has evidence of intraluminal thrombus.
  6. The study vessel has evidence of moderate to severe tortuosity (>90°) proximal to the target lesion.
  7. The study lesion has any of the following characteristics:

    • Total occlusion.
    • Ostial location.
    • Is within 2.0 mm of a side branch measuring >2.0 mm in diameter.
    • Located at < 45° bend in the vessel.
    • Moderately to severely calcified.
    • Moderate to severe calcification in the vessel proximal to the target lesion.
    • Located in a native vessel distal to an anastomosis, with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass, and is approached through the bypass graft.
  8. Unprotected left main coronary artery disease defined as 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: NCT01275092

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Northeast Georgia Heart Center
Gainesville, Georgia, United States, 30501
United States, Massachusetts
St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Saint Joseph's Hospital
Syracuse, New York, United States, 13203
United States, Tennessee
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States, 37660
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Colombia
CORBIC
Medellin, Colombia
Sponsors and Collaborators
Corindus Inc.
Investigators
Study Director: Michail Pankratov, MD/PhD Corindus Inc.
  More Information

Additional Information:
No publications provided by Corindus Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Corindus Inc.
ClinicalTrials.gov Identifier: NCT01275092     History of Changes
Other Study ID Numbers: CorPath PRECISE
Study First Received: January 7, 2011
Results First Received: August 9, 2012
Last Updated: August 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Corindus Inc.:
robotic-assisted PCI
coronary intervention
CorPath PRECISE
PCI

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

ClinicalTrials.gov processed this record on November 20, 2014