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

NCT01076036 | Completed Phase 2 Results DMC

• 1 other identifier: Corindus-Corbic-2010
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

ischemia; stent

Outcome Measures

Primary Outcomes (2)

• Clinical Procedural Success

  The percentage of Participants with \<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)

  48-hrs or hospital discharge, whichever occurs first

• Procedural Technical Success

  Successful robotic delivery and retraction of all PCI devices during CorPath PCI procedure.

  Intervention

Study Arms (1)

CorPath 200 System

EXPERIMENTAL

Robotic-assisted PCI with the CorPath 200

Device: CorPath 200

Interventions

CorPath 200 DEVICE

CorPath™ 200 robotically-assisted percutaneous coronary intervention

CorPath 200 System

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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:
• Total occlusion

Sponsors & Collaborators

• Corindus Inc.: lead

Study Sites (1)

CORBIC Cardio-Neuro-Vascular Institute

Medellín, Colombia

Location

MeSH Terms

Conditions

Coronary Artery Disease; Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michail M. Pankratov, MD, PhD, Vice President of Clinical & Regulatory Affairs
• Organization: Corindus, Inc

Michail.Pankratov@Corindus.com

508-653-3335

Study Officials

• Juan F Granada, MD

  CORBIC and CRF

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: February 24, 2010
• First Posted: February 25, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 7, 2015
• Results First Posted: September 7, 2015

Record last verified: 2015-08

Locations

CO (1)