RESOLUTE INTEGRITY US

Overview

Status: Completed
Keywords: Cardiovascular Disease , Stents
IRB Number: 00061254
Specialty: Cardiology
Sub Specialties: Interventional Cardiology

Brief Summary

Purpose

The purpose of this post-approval study is to conduct a prospective, multi-center evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Objective

To assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2mm

Principal Investigator: Rodney Badger
Department: Cardiology
Co Investigator: Brigham Smith
Co Investigator: Anwar Tandar

Contact Information

Name:Renee Neuharth
Phone: 801-587-4877
Email: Renee.Neuharth@hsc.utah.edu

Inclusion Criteria

General Inclusion Criteria

Patient must meet all of the following criteria to be eligible for treatment in the trial:

1. Patient is > 18 years old

2. Patient is an acceptable candidate for percutaneous coronary intervention (PCI), stenting,

and emergent coronary artery bypass graft (CABG) surgery

3. Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent

ischemia, and/or a positive functional study

4. Female patients of childbearing potential must have a negative pregnancy test within 7

days before the trial procedure

5. Patient or patient’s legal representative has been informed of the nature of the trial and

agrees to its provisions and has provided written informed consent as approved by the

Institutional Review Board (IRB) of the respective investigational site.

6. Patient agrees to return to the site where the procedure was performed for a clinic visit

and 12-lead ECG at 12 months and to participate in follow-up assessments at 30 days, 6

months, and 24 months post procedure.

Angiographic Inclusion Criteria

The patient and each target lesion/vessel must meet all of the following angiographic criteria for the patient to be considered for inclusion in the trial:

1. Patient has either a single target lesion, or two target lesions located in separate target vessels

2. Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)

3. Target lesion(s) must be  27 mm in length

4. Target lesion(s) must have a stenosis of  50% and < 100%

5. Target vessel(s) must have a reference vessel diameter (RVD) of 2.25 to 4.2 mm

6. Target vessel(s) must have a thrombolysis in myocardial infarction (TIMI) flow  2

Note: Measurements may be made by careful visual estimate, on-line QCA, or IVUS.

 

Exclusion Criteria

General Exclusion Criteria

Patients will be excluded from the trial if any of the following criteria are met:

1. Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, clopidogrel and ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a

sensitivity to contrast media, which cannot be adequately pre-medicated

2. History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative

3. Platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³ within 7 days prior to index procedure

4. Serum creatinine level > 2.5 mg/dl within 7 days prior to index procedure

5. Evidence of an acute MI within 72 hours of the intended trial procedure:

a) Q wave myocardial infarction (QWMI);

OR,

b) Any elevation of CK-MB isoenzyme above the laboratory upper limit of normal and has not

returned to normal at the time of the index procedure

Note: Patients with evidence or suspicion of an acute MI (per Investigator or Sub-Investigator determination) or with an elevation of total CK greater than 2 times the laboratory upper limit of normal must have CK-MB results reviewed prior to enrollment.

6. Previous percutaneous coronary intervention (PCI) of the target vessel(s) within 9 months prior to the procedure

Note: Refer to Table 5-2 in Section 5.5.5 for criteria of previous PCI to the target and other (nontarget)

vessel(s).

7. Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of the target vessel(s) within 12 months post-procedure.

Note: Refer to Table 5-2 in Section 5.5.5 for additional procedure criteria for planned PCI of the target and other (non-target) vessel(s)

8. During the index procedure, the target lesion(s) requires treatment with a device other than

percutaneous transluminal coronary angiography (PTCA) prior to stent placement (including, but not limited to, cutting/scoring balloon, atherectomy, laser, thrombectomy, etc.)

9. History of a stroke or transient ischemic attack (TIA) within the prior 6 months

10. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months

11. History of bleeding diathesis or coagulopathy or will refuse blood transfusions

12. Concurrent medical condition with a life expectancy of less than 12 months

13. Any previous treatment of the target vessel(s) for restenosis, including brachytherapy

14. Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures

Note: Trials requiring extended follow-up for products that were investigational, but have

since become commercially available, are not considered investigational trials.

15. Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation

16. Inability to comply with the required study antiplatelet regimen (see Section 6.3)

Angiographic Exclusion Criteria

Patients will be excluded from the trial if any of the following criteria are met (for patients with two target lesions, both target lesions/vessels must not meet any of the criteria below):

1. Target lesion(s) are located in native vessel(s) distal to anastomosis with a bypass graft (including but not limited to saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA)) with more than 40% diameter stenosis anywhere within the graft

Note: A target lesion distal to a graft may be accessed through the graft.

2. Previous stenting in the target vessel(s) unless the following conditions are met:

a) It has been at least 9 months since the previous stenting, and

b) The target lesion(s) is/are at least 15 mm away from the previously placed stent

3. Target vessel(s) has/have other lesions with greater than 40% diameter stenosis based on visual estimate or on-line QCA

4. The target vessel(s) has/have evidence of thrombus

5. The target vessel(s) is/are excessively tortuous (two bends  90º to reach the target lesion)

6. The target lesion(s) has/have any of the following characteristics:

a) Lesion location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin

of the left anterior descending (LAD) or left circumflex (LCX)

b) Involves a side branch > 2.0 mm in diameter

c) Is at or distal to a > 45º bend in the vessel

d) Is severely calcified          

7. Unprotected left main coronary artery disease (an obstruction greater than 50% in the left main coronary artery)