Clinical trial NCT01076036: CorPath™ 200: Robotically-Assisted Percutaneous Coronary Intervention (PCI)
Official title: CorPath™ 200 System: Coronary Remote Catheterization Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: ischemia
stent
Lead sponsor: Corindus Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Objective The study objective was to evaluate the safety and technical efficacy of the CorPath 200 System in delivery and manipulation of commercially available coronary guidewires and rapid exchange balloon/stent catheter for use in percutaneous coronary interventions (PCI).

I. Primary Endpoints A. Efficacy Device Clinical Success: Achievement of a \< 30% final diameter stenosis after utilizing the CorPathTM 200 System to deliver a PTCA balloon and then stent to the target lesion, and successfully retract the devices without the occurrence of any In-Hospital MACE (Major Adverse Cardiac Event) evaluated at 48 hours post procedure or hospital discharge, whichever occurs first.

B. Safety In-Hospital MACE: Defined as the composite of death (all cause mortality), recurrent MI, and target vessel revascularization (emergent coronary artery bypass surgery \[CABG\] or PCI) evaluated at 48 hours post procedure or hospital discharge, whichever occurs first.

II. Secondary Endpoints A. Efficacy CorPath Success: Ability to navigate the guide wire and balloon/stent system utilizing the CorPath™ device to the target site without the occurrence of any In-Hospital MACE, evaluated at 48 hours post index procedure or hospital discharge, whichever occurs first.

Subject Clinical Success: Achievement of a \<30% final diameter stenosis of target lesion after treatment with PTCA/coronary stent without the occurrence of any In-Hospital MACE, evaluated at 48 hours post-index procedure or hospital discharge, whichever occurs first.

B. Safety:

MACE at 30 Days: Defined as the composite of death, recurrent MI and/or target vessel revascularization (emergent coronary artery bypass surgery \[CABG\] or PCI) evaluated at 30 days post index procedure.

Adverse Events:

A summary of all adverse events observed in the trial summarized as either serious or non-serious and summarized by attribution.

C. Clinical Utility

Procedure Attributes:

* Reduction in radiation exposure to the primary operator based on radiation dosimetry measurements at the procedure table and on a primary operator.
* Total Procedure time based on the time of insertion of hemostasis sheath through the time of final guide catheter withdrawal.

CorPath Device Attributes:

Subjective assessment by the operator of the following device performance attributes:

* Movement of the guide wire (rotating and advancing) to the target.
* Maneuvering and position of the guide wire to the target.
* Movement of the stent/balloon (advancing) to the target.
* Ability to deliver the PTCA/stent system to the intended target lesion.
* Ease of use of the system by the interventional team.

Material \& Methods Corindus obtained approval (from the CORBIC Ethics Committee and INVIMA - Colombian Ministry of Health) in 2009 to conduct the clinical study "CorPath™ 200 System: Coronary Remote Catheterization Feasibility Study" at CORBIC Cardio-Neuro-Vascular Institute, Envigado, Colombia.

The study is a single arm, open label, prospective registry to treat a de novo lesion (2.5 mm - 4.0 mm in diameter, 25.0 mm in length with \>50% stenosis) utilizing the CorPath 200 System to deliver, manipulate and retrieve a guidewire and a balloon/stent catheter system.

Eligibility 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).

Primary outcomes:
measure: Clinical Procedural Success
timeFrame: 48-hrs or hospital discharge, whichever occurs first
measure: Procedural Technical Success
timeFrame: Intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: CORBIC Cardio-Neuro-Vascular Institute
Study officials:
affiliation: CORBIC and CRF
name: Juan F Granada, MD
role: PRINCIPAL_INVESTIGATOR
References: