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

NCT01275092 | Completed Phase 2 Results DMC

• 1 other identifier: CorPath PRECISE
• Study Type: interventional
• Target: 164
• Locations: 2 countries
• Sites: 9

Brief Summary

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).

Conditions

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Keywords

robotic-assisted PCI; coronary intervention; CorPath PRECISE; PCI

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Clinical Procedural Success

  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.

  48-hrs or hospital discharge, whichever occurs first

• Percentage of Patients With Device Technical Success

  Defined as the successful advancement and retraction of PCI devices using the CorPath 200 System and without conversion to manual operation.

  1 day

Secondary Outcomes (1)

• The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table

  1 day

Study Arms (1)

CorPath robotic-assisted PCI

EXPERIMENTAL

CorPath 200 robotic-assisted PCI

Device: CorPath robotic-assisted PCI

Interventions

CorPath robotic-assisted PCI DEVICE

CorPath 200® robotic-assisted percutaneous coronary intervention

CorPath robotic-assisted PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between 18 and 99 years of age.
• Subject is an acceptable candidate for PCI.
• 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 7 days prior to the CorPath 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.
• 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.
• Study reference vessel diameter is between 2.5mm and 4.0mm by visual estimate.
• Study lesion length is less than or equal to 24.0mm by visual estimate.
• Study lesion diameter showing stenosis of at least 50% by visual estimate.

You may not qualify if:

• Subject requires planned PCI or CABG (Coronary Artery Bypass Graft) within 30 days following the CorPath procedure.
• Evidence of an acute myocardial infarction within 72 hours prior to the intended CorPath procedure.
• Subject has documented left ventricular ejection fraction \<30%.
• Subject has undergone PCI within 72 hours prior to the CorPath procedure.
• 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.
• 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.
• 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).
• 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.
• Subject has suffered a stroke within 30 days prior to planned CorPath procedure.
• Subject has an active peptic ulcer or upper gastrointestinal bleeding within the 6 months prior to planned CorPath procedure.
• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Subject is currently participating in another investigational drug or drug/device or device trial and has not completed the entire follow up period.
• Femoral access is not possible.
• Target lesion that cannot be fully covered by a single stent.
• Subject requires treatment of more than one vessel.

Sponsors & Collaborators

• Corindus Inc.: lead

Study Sites (9)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Northeast Georgia Heart Center

Gainesville, Georgia, 30501, United States

Location

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Saint Joseph's Hospital

Syracuse, New York, 13203, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

CORBIC

Medellín, Colombia

Location

Related Publications (1)

• 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.

  PMID: 23500318 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Giora Weisz, MD; Director of Clinical Resarch Center for Interven tional Vascular Therapy
• Organization: Columbia University Medical Center, New York, NY, 10032

gweisz@crf.org

212-305-7060

Study Officials

• Michail Pankratov, MD/PhD

  Corindus Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 12, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: August 8, 2013
• Results First Posted: August 8, 2013

Record last verified: 2013-08

Locations

US (8); CO (1)