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

Phase 2

Completed

• Conditions: Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases
• Interventions: Device: CorPath robotic-assisted PCI

• Registration Number: NCT01275092
• Lead Sponsor: Corindus Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-07
• Study First Submitted QC: 2011-01-10
• Study First Posted: 2011-01-12
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Results First Submitted: 2012-08-09
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-06
• Last Update Submitted: 2013-08-06
• Results First Posted: 2013-08-08
• Last Update Posted: 2013-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CorPath robotic-assisted PCI	CorPath robotic-assisted PCI	CorPath 200 robotic-assisted PCI

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Clinical Procedural Success	48-hrs or hospital discharge, whichever occurs first	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	1 day	Defined as the successful advancement and retraction of PCI devices using the CorPath 200 System and without conversion to manual operation.

Secondary Outcome Measures

Name	Time	Method
The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table	1 day	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.

Trial Locations

Locations (9)

St. Elizabeth's Medical Center; 🇺🇸 Boston, Massachusetts, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

Northeast Georgia Heart Center; 🇺🇸 Gainesville, Georgia, United States

CORBIC; 🇨🇴 Medellin, Colombia

Saint Joseph's Hospital; 🇺🇸 Syracuse, New York, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Wellmont CVA Heart Institute; 🇺🇸 Kingsport, Tennessee, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States