Clinical trial NCT01080261: PROMUS Element Japan Small Vessel Trial
Official title: A Prospective Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of a Small Vessel De Novo Coronary Artery Lesion in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atherosclerosis
Coronary Artery Disease
Keywords: Atherosclerosis
Coronary Artery Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A non-randomized, small vessel (SV) trial at approximately 15 sites in Japan to enroll 60 patients with a de novo lesion ≤28 mm in length (by visual estimate) in a native coronary artery ≥2.25 mm to \<2.50 mm in diameter (by visual estimate). Approximately thirty patients will be randomly assigned to the angiographic subset to also undergo angiographic assessment after the 12-month clinical follow-up.


Eligibility criteria: Inclusion Criteria:

* Patient must be at least 20 years of age
* Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
* Patient is eligible for percutaneous coronary intervention (PCI) with regards to the target lesion Patient is considered suitable for PCI if any of the following criteria meet.
* Evidence of ischemia documented with stress electrocardiogram (ECG) and/or any diagnostic imaging tests.
* Target vessel supplies blood to relatively large area of the myocardium.
* Target lesion is a possible culprit of angina.
* Target vessel is a potential collateral source for other major vessels
* Patient has documented stable angina pectoris or documented silent ischemia; or unstable angina pectoris
* Patient is an acceptable candidate for coronary artery bypass grafting (CABG)
* Patient has a left ventricular ejection fraction (LVEF) ≥30% as measured within 30 days prior to enrollment
* Patient is willing to comply with all protocol-required follow-up evaluation

Exclusion Criteria:

* Patient has clinical symptoms and/or ECG changes consistent with acute myocardial infarction (MI)
* Patient has had a known diagnosis of recent MI (i.e., within 72 hours prior to the index procedure) and has elevated enzymes at the time of the index procedure as follows.

  * Patients are excluded if any of the following criteria are met at the time of the index procedure.
  * If creatine kinase-myoglobin band (CK-MB) is \>2× upper limit of normal (ULN), the patient is excluded regardless of the CK Total.
  * If CK MB is 1 2× ULN, the patient is excluded if the CK Total is \>2× ULN.
  * If CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at the time of the index procedure.
  * Troponin \>1× ULN with at least one of the following.
  * Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (e.g., \>1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block \[LBBB\]);
  * Development of pathological Q waves in the ECG; or
  * Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

Note: For patients with unstable angina or patients who have had a recent MI, CK Total/CK MB (or Troponin if CK Total/CK MB are not used) must be documented prior to enrolling the patient.

* Patient has received an organ transplant or is on a waiting list for an organ transplant
* Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
* Patient is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
* Patient is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, warfarin) for indications other than acute coronary syndrome
* Patient has a platelet count \<100,000 cells/mm\^3 or \>700,000 cells/mm\^3
* Patient has a white blood cell (WBC) count \<3,000 cells/mm\^3
* Patient has documented or suspected liver disease, including laboratory evidence of hepatitis
* Patient is on dialysis or has known renal insufficiency (i.e., Creatinine \> 2.0 mg/dl or \>150 μmol/L)
* Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
* Target vessel or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure (excluding PCI of the non-target lesion within the target vessel treated during the index procedure (Refer to Multiple Interventions During Index Procedure))
* Target vessel has been treated within 10 mm proximal or distal to the target lesion (by visual estimate) with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to the index procedure
* Non-target vessel or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to the index procedure
* Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement
* Planned PCI or CABG after the index procedure
* Patient previously treated at any time with coronary intravascular brachytherapy
* Patient has a known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
* Patient has an active peptic ulcer or active gastrointestinal (GI) bleeding
* Patient has one of the following.

  * Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to 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
* Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
* Patient intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
* Patient 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.)
* Patient 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.)
* Patient has more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure

Primary outcomes:
measure: Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event)
timeFrame: 9 months
Secondary outcomes:
measure: Myocardial Infarction (MI) (Percentage of Participants With an Event)
timeFrame: 9 months
measure: All-cause Death (Percentage of Participants With an Event)
timeFrame: 9 months
measure: Cardiac Death (Percentage of Participants With an Event)
timeFrame: 9 months
measure: Target Vessel Revascularization (Percentage of Participants With an Event)
timeFrame: 9 months
measure: Target Lesion Revascularization (Percentage of Participants With an Event)
timeFrame: 9 months
measure: Target Vessel Failure (TVF) (Percentage of Participants With an Event)
timeFrame: 9 months
measure: Target Lesion Failure (TLF) (Percentage of Participants With an Event)
timeFrame: 9 months
measure: Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)
timeFrame: 0-30 Days (Early)
measure: Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)
timeFrame: >30 days - 9 months
measure: Technical Success (Percentage of Stents)
timeFrame: At time of index procedure
measure: Clinical Procedural Success (Percentage of Participants)
timeFrame: While participant is in the hospital
Other outcomes:
Locations:
city: Kitakyushu-shi
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka-ken
city: Koriyama-shi
country: Japan
facility: Hoshi General Hospital
state: Fukushima-ken
city: Hakodate-shi
country: Japan
facility: Hakodate Municipal Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hokkaido Social Insurance Hospital
state: Hokkaido
city: Kamakura-shi
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa-ken
city: Kawasaki-shi
country: Japan
facility: Japan Labour Health and Welfare Organization Kanto Rosai Hospital
state: Kanagawa-ken
city: Yokohama City
country: Japan
facility: Saiseikai Yokohama-City Eastern Hospital
state: Kanagawa-ken
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa-ken
city: Yatsushiro-shi
country: Japan
facility: Japan Labour Health and Welfare Organization Kumamoto Rosai Hospital
state: Kumamoto-ken
city: Kyoto-shi
country: Japan
facility: Kyoto-Katsura Hospital
state: Kyoto-fu
city: Kurashiki-shi
country: Japan
facility: Kurashiki Central Hospital
state: Okayama-ken
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi-ken
city: Minato-ku
country: Japan
facility: The Cardiovascular Institute Hospital
state: Tokyo-to
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo-to
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo-tu
Study officials:
affiliation: Shonan Kamakura General Hospital
name: Shigeru Saito, MD
role: PRINCIPAL_INVESTIGATOR
References: