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

Coronary Artery Disease Clinical Trial

— PRECISE  

Official title:

CorPath® PRECISE Percutaneous Robotically-Enhanced Coronary Intervention Study (PRECISE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275092
• Other study ID #: CorPath PRECISE
• Status: Completed
• Phase: Phase 2
• First received: January 7, 2011
• Last updated: August 6, 2013
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: August 2013
• Source: Corindus Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

General 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• CorPath robotic-assisted PCI
CorPath 200® robotic-assisted percutaneous coronary intervention

Locations

Country	Name	City	State
Colombia	CORBIC	Medellin
United States	St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Northeast Georgia Heart Center	Gainesville	Georgia
United States	Wellmont CVA Heart Institute	Kingsport	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Swedish Medical Center	Seattle	Washington
United States	Saint Joseph's Hospital	Syracuse	New York
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Corindus Inc.

Countries where clinical trial is conducted

United States,  Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table	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.	1 day	Yes

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