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

• Sponsor: Corindus Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01275092
• Collaborator: (none)
• Enrollment: 164
• Locations: 9
• Arm: 1
• Duration (Months): 12
• Patients Per Site: 18.2
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases	Device: CorPath robotic-assisted PCI	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 164 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CorPath® PRECISE Percutaneous Robotically-Enhanced Coronary Intervention Study (PRECISE)
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CorPath robotic-assisted PCI CorPath 200 robotic-assisted PCI	Device: CorPath robotic-assisted PCI; CorPath 200® robotic-assisted percutaneous coronary intervention

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Unprotected left main coronary artery disease defined as an obstruction greater than 50% diameter stenosis in the left main coronary artery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington Hospital Center	Washington	District of Columbia	United States	20010
2	Northeast Georgia Heart Center	Gainesville	Georgia	United States	30501
3	St. Elizabeth's Medical Center	Boston	Massachusetts	United States	02135
4	Columbia University Medical Center	New York	New York	United States	10032
5	Saint Joseph's Hospital	Syracuse	New York	United States	13203
6	Wellmont CVA Heart Institute	Kingsport	Tennessee	United States	37660
7	Virginia Commonwealth University	Richmond	Virginia	United States	23298
8	Swedish Medical Center	Seattle	Washington	United States	98122
9	CORBIC	Medellin		Colombia

Sponsors and Collaborators

• Corindus Inc.

Investigators

• Study Director: Michail Pankratov, MD/PhD, Corindus Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Corindus Inc.
• ClinicalTrials.gov Identifier: NCT01275092
• Other Study ID Numbers: CorPath PRECISE
• First Posted: Jan 12, 2011
• Last Update Posted: Aug 8, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by Corindus Inc.: robotic-assisted PCI; coronary intervention; CorPath PRECISE; PCI
• Additional relevant MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Ischemia

Study Results

Participant Flow

Recruitment Details	During January-December 2011 period 164 participants were enrolled in the PRECISE study at 9 clinical sites

Arm/Group Title	CorPath Robotic-assisted PCI
Arm/Group Description	CorPath 200 robotic-assisted PCI
Period Title: Overall Study
STARTED	164
COMPLETED	164
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	CorPath Robotic-assisted PCI
Arm/Group Description	CorPath 200 robotic-assisted PCI
Overall Participants	164
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	87 53%
>=65 years	77 47%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.1 (10.0)
Sex: Female, Male (Count of Participants)
Female	42 25.6%
Male	122 74.4%
Region of Enrollment (participants) [Number]
United States	144 87.8%
Colombia	20 12.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Clinical Procedural Success
Description	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.
Time Frame	48-hrs or hospital discharge, whichever occurs first

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CorPath Robotic-assisted PCI
Arm/Group Description	CorPath 200 robotic-assisted PCI
Measure Participants	164
Number (95% Confidence Interval) [percentage of participants]	97.6 59.5%

2. Primary Outcome

Title	Percentage of Patients With Device Technical Success
Description	Defined as the successful advancement and retraction of PCI devices using the CorPath 200 System and without conversion to manual operation.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CorPath Robotic-assisted PCI
Arm/Group Description	CorPath 200 robotic-assisted PCI
Measure Participants	164
Number (95% Confidence Interval) [percentage of participants]	98.8 60.2%

3. Secondary Outcome

Title	The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CorPath Robotic-assisted PCI
Arm/Group Description	CorPath 200 robotic-assisted PCI
Measure Participants	164
Median (Inter-Quartile Range) [ratio]	0.42

Adverse Events

Time Frame	1 month
Arm/Group Title	CorPath Robotic-assisted PCI
Arm/Group Description	CorPath 200 robotic-assisted PCI
All Cause Mortality
	CorPath Robotic-assisted PCI
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	CorPath Robotic-assisted PCI
	Affected / at Risk (%)	# Events
Total	28/164 (17.1%)
General disorders
Others	1/164 (0.6%)	5
Vascular disorders
cardiovascular complications	27/164 (16.5%)	28
Other (Not Including Serious) Adverse Events
	CorPath Robotic-assisted PCI
	Affected / at Risk (%)	# Events
Total	62/164 (37.8%)
General disorders
Others	36/164 (22%)	36
Vascular disorders
Cardiovascular complications	26/164 (15.9%)	26

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.