Evaluation of the Safety and Effectiveness of the CorPath 200 System in Percutaneous Coronary Interventions (PCI)
NCT ID: NCT01275092
Last Updated: 2013-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
164 participants
INTERVENTIONAL
2011-01-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CorPath robotic-assisted PCI
CorPath 200 robotic-assisted PCI
CorPath robotic-assisted PCI
CorPath 200® robotic-assisted percutaneous coronary intervention
Interventions
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CorPath robotic-assisted PCI
CorPath 200® robotic-assisted percutaneous coronary intervention
Eligibility Criteria
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Inclusion Criteria
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.
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.
Exclusion Criteria
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.
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.
18 Years
ALL
No
Sponsors
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Corindus Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michail Pankratov, MD/PhD
Role: STUDY_DIRECTOR
Corindus Inc.
Locations
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Washington Hospital Center
Washington D.C., District of Columbia, United States
Northeast Georgia Heart Center
Gainesville, Georgia, United States
St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Columbia University Medical Center
New York, New York, United States
Saint Joseph's Hospital
Syracuse, New York, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
CORBIC
Medellín, , Colombia
Countries
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References
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Weisz G, Metzger DC, Caputo RP, Delgado JA, Marshall JJ, Vetrovec GW, Reisman M, Waksman R, Granada JF, Novack V, Moses JW, Carrozza JP. Safety and feasibility of robotic percutaneous coronary intervention: PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) Study. J Am Coll Cardiol. 2013 Apr 16;61(15):1596-600. doi: 10.1016/j.jacc.2012.12.045.
Other Identifiers
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CorPath PRECISE
Identifier Type: -
Identifier Source: org_study_id