Clinical trial NCT01703000: NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Coronary Artery Disease
Keywords: drug eluting coronary stent
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-10-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: Clinical 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

Angiographic Inclusion Criteria:

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.

Clinical 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)

Angiographic Exclusion Criteria:

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)

Primary outcomes:
measure: Technical Success Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcomes:
measure: Target Lesion Revascularization (TLR) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
measure: Target Lesion Failure (TLF) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
measure: Target Vessel Revascularization (TVR) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
measure: Target Vessel Failure (TVF) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
measure: Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
measure: Cardiac Death Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
measure: Non-cardiac Death Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
measure: All Death Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
measure: Cardiac Death or MI Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
measure: All Death or MI Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
measure: All Death/MI/TVR Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
measure: Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
measure: Clinical Procedural Success Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: In-stent Percent Diameter Stenosis (%DS)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: In-segment Percent Diameter Stenosis (%DS)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: In-stent Minimum Lumen Diameter (MLD)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: In-segment Minimum Lumen Diameter (MLD)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Acute Gain
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Vessel Area
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Stent Area
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Lumen Area
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Vessel Volume
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Stent Volume
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Lumen Volume
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Incomplete Apposition
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Percent Net Volume Obstruction
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Longitudinal Stent Deformation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Other outcomes:
Locations:
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Auckland
country: New Zealand
facility: Mercy Angiography Unit, Ltd. Mercy Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Auckland
country: New Zealand
facility: Ascot Angiography
city: Christchurch
country: New Zealand
facility: Christchurch
city: Otahuhu
country: New Zealand
facility: Middlemore Hospital
city: Singapore
country: Singapore
facility: National University Hospital Singapore
city: Singapore
country: Singapore
facility: National Heart Center Singapore
Study officials:
affiliation: Mercy Angiography Unit, Ltd. Mercy Hospital
name: John A Ormiston, MBChB, FRACP, FRACR
role: PRINCIPAL_INVESTIGATOR
References: