A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population

NCT ID: NCT01115933

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease caused by de novo lesions.

Conditions

Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XIENCE PRIME SV EECSS

XIENCE PRIME SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System

Group Type: EXPERIMENTAL

XIENCE PRIME SV EECSS

Intervention Type: DEVICE

Patients receiving XIENCE PRIME SV EECSS

Interventions

XIENCE PRIME SV EECSS

Patients receiving XIENCE PRIME SV EECSS

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject must be at least 20 years of age.

2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.

3. Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).

4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.

5. Subject must agree to undergo all protocol-required follow-up procedures.

6. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

1. One (target) or two (one target and one non-target) de novo lesions each in a different epicardial vessel.

2. Lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.

3. Lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.25 mm and < 2.5 mm.

4. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 22 mm.

Exclusion Criteria

1. Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure.

2. The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.

3. Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.

4. Subject has a known left ventricular ejection fraction (LVEF) < 40% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).

5. Subject has received coronary brachytherapy in any epicardial vessel.

6. Subject has received any organ transplant or is on a waiting list for any organ transplant.

7. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.

8. Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.

9. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).

10. Subject is receiving chronic anticoagulation therapy (e.g., heparin, warfarin).

11. Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.

12. Subject has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.

13. Elective surgery is planned within 6 months after the procedure that will require discontinuing either aspirin or clopidogrel.

14. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).

15. Subject has known renal insufficiency (examples being but not limited to serum creatinine level ≥ 2.0 mg/dL, or on dialysis).

16. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.

17. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.

18. Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.

19. Subject has extensive peripheral vascular disease that precludes safe 5 French catheter insertion.

20. Subject has other medical illness (e.g., cancer) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).

21. Subject is currently participating in another clinical study that has not yet completed its primary endpoint.

22. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test*.

• Whether a subject who met this criterion will be asked for pregnancy test will be decided per site standard. However, subject enrollment in the study is not allowed without pregnancy test result.

1. Target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or saphenous vein graft.

2. Target lesion involving a bifurcation with a side branch ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guidewire, or side branch requiring dilatation.

3. Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.

4. Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion.

5. Restenotic lesion.

6. Aorto-ostial target lesion (within 3 mm of the aorta junction).

7. Lesion in the left main trunk (both target and non-target).

8. Lesion located within 2 mm of the origin of the LAD or LCX.

9. Extreme angulation (≥ 90 °) or excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.

10. Heavy calcification proximal to or within the target lesion.

11. Target vessel contains thrombus as indicated in the angiographic images.

12. Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. rotablator, DCA, cutting balloon).

13. Target vessel is previously treated* with any type of PCI (e.g. balloon angioplasty, stent, rotablator, DCA, cutting balloon) within 9 months of index procedure.

14. Non-target vessel was previously treated with any type of PCI within 90 days of index procedure.

15. Additional clinically significant lesion(s) in the target vessel or side branch for which PCI may be required within 90 days after the index procedure.

• Target lesion must be separated ≥ 5 mm from a previously treated lesion (stenosis within 5 mm of previously treated lesion is regarded as "restenosis").

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takaaki Isshiki, MD

Role: PRINCIPAL_INVESTIGATOR

Teikyo University Hospital

Locations

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Hokkaido Social Insurance Hospital Cardiovascular Center

Toyohira, Hokkaido, Japan

Teikyo University

Tokyo, Itabashi, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Saiseikai Yokohama City Eastern Hospital

Yokohama, Kanagawa, Japan

Kumamoto Central Hospital

Kumamoto, Kumamoto, Japan

Kyoto University Hospital

Sakyo-ku, Kyoto, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Nagoya Daini Red Cross Hospital

Shōwaku, Nagoya, Japan

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Sakurabashi Watanabe Hospital

Kita-ku, Osaka, Japan

Osaka University Hospital

Suita, Osaka, Japan

Tokushima Red Cross Hospital

Komatsushimachō, Tokushima, Japan

Countries

Japan

Other Identifiers

09-385

Identifier Type: -

Identifier Source: org_study_id