NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions

NCT ID: NCT01703000

Last Updated: 2014-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-03-31

Brief Summary

NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting Platinum Chromium Coronary Stent System (NG PROMUS Stent System) for the Treatment of Atherosclerotic Lesion(s)

Detailed Description

To evaluate clinical and peri-procedural angiographic and intravascular ultrasound (IVUS) outcomes for the NG PROMUS Everolimus-Eluting Platinum Chromium Coronary Stent System (NG PROMUS Stent System) in the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥ 2.50 mm to ≤ 4.0 mm in diameter (by visual estimate)

Conditions

Atherosclerosis; Coronary Artery Disease

Study Design

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

Study Groups

NG PROMUS stent

Single-arm treatment group receiving interventional NG PROMUS study stent

Group Type: EXPERIMENTAL

Percutaneous coronary intervention (NG PROMUS)

Intervention Type: DEVICE

Interventional coronary artery stenting with NG PROMUS study stent.

Interventions

Percutaneous coronary intervention (NG PROMUS)

Interventional coronary artery stenting with NG PROMUS study stent.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject must be at least 18 years of age

2. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed

3. Subject is eligible for percutaneous coronary intervention (PCI)

4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia

5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)

6. Subject is willing to comply with all protocol-required follow-up evaluation

1. Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.50 mm and ≤4.0 mm

2. Target lesion(s) length must be ≤34 mm (by visual estimate)

3. Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following (stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress test or imaging stress test, or elevated biomarkers) prior to procedure

4. Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)

5. The first lesion treated must be successfully pre-dilated/pretreated Note: Successful pre-dilatation/pretreatment refers to dilatation with a balloon catheter of appropriate length and diameter, or pretreatment with directional or rotational coronary atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.

Exclusion Criteria

1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)

2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina

3. Subject has received an organ transplant or is on a waiting list for an organ transplant

4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure

5. Planned PCI (including staged procedures) or CABG after the index procedure

6. Subject previously treated at any time with intravascular brachytherapy

7. Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)

8. Subject has one of the following (as assessed prior to the index procedure):Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months; Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.);Planned procedure that may cause non-compliance with the protocol or confound data interpretation

9. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome

10. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3

11. Subject has a white blood cell (WBC) count < 3,000 cells/mm3

12. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis

13. Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)

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

15. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months

16. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding

17. Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the time of the index procedure

18. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint

19. Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure

20. Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)

21. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)

1. Planned treatment of more than 3 lesions.

2. Planned treatment of lesions in more than 2 major epicardial vessels

3. Planned treatment of a single lesion with more than 1 stent

4. Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)

5. Target lesion(s) is located in the left main

6. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate.

7. Target lesion(s) is located within a saphenous vein graft or an arterial graft

8. Target lesion(s) will be accessed via a saphenous vein graft or arterial graft

9. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing

10. Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)

11. Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent

12. Subject has unprotected left main coronary artery disease (>50% diameter stenosis)

13. Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure

14. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John A Ormiston, MBChB, FRACP, FRACR

Role: PRINCIPAL_INVESTIGATOR

Mercy Angiography Unit, Ltd. Mercy Hospital

Locations

Fremantle Hospital

Fremantle, Western Australia, Australia

Mercy Angiography Unit, Ltd. Mercy Hospital

Auckland, , New Zealand

Auckland City Hospital

Auckland, , New Zealand

North Shore Hospital

Auckland, , New Zealand

Ascot Angiography

Auckland, , New Zealand

Christchurch

Christchurch, , New Zealand

Middlemore Hospital

Otahuhu, , New Zealand

National University Hospital Singapore

Singapore, , Singapore

National Heart Center Singapore

Singapore, , Singapore

Countries

Australia; New Zealand; Singapore

Related Links

http://www.pharma.us.novartis.com/info/products/name/zortress.jsp

Drug-eluting product information from Manufacturer

Other Identifiers

NG PROMUS Clinical Trial S2294

Identifier Type: -

Identifier Source: org_study_id