The primary objective of this study is to demonstrate the clinical performance of PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint for the study is the TVF rate at 9 months post-index
procedure.
The TVF rate includes a composite of cardiac death, MI and TVR. The definition
of cardiac death follows the Academic Research Consortium (ARC) recommendation
of any death adjudicated by the independent CEC as cardiac in origin.19 All
deaths reported during the study will be considered cardiac, unless an
unequivocal, non-cardiac cause is indicated on the subject*s death report.
Cardiac death will include all deaths related to a cardiac diagnosis,
complication of the index procedure, treatment for a complication of the index
procedure or an unexplained cause. Likewise, any unexpected death reported
during the study of a subject with a co-existing and potentially fatal
non-cardiac disease will be classified as cardiac in nature, unless subject
history related to the non-cardiac diagnosis suggests death was imminent.
Secondary outcome
Event rates will be estimated for the following endpoints at 1, 9, 12, 24 and
36 months post-index procedure unless otherwise noted:
* TVF rate (primary endpoint at 9 months)
* Individual components of the TVF rate (cardiac death, MI, ischemia-driven
TVR)
* Overall TVR rate
* TLF rate, including individual components of the TLF rate (cardiac death, MI,
ischemia-driven TLR)
* Overall TLR rate
* Rate of all cause mortality and all cause MI, including individual components
* Stent thrombosis rate
* Index procedure success
* Device success
* Lesion success
* Angina pectoris classification
* Rates for individual adverse events
Background summary
Coronary artery disease is a common, but serious condition occurring with the
formation of atherosclerotic plaque inside the arteries supplying blood to the
heart. The buildup of plaque, or atherosclerosis, is caused by the collection
of cholesterol and fat circulating in the blood stream. Over time,
atherosclerosis causes a narrowing or blockage of the coronary arteries,
thereby preventing oxygen-rich blood from reaching the heart muscle. This can
result in symptoms of angina which may manifest as chest pain, shortness of
breath or heart attack. Coronary artery disease affects approximately 16
million American adults and is the leading cause of death in the United States
among both men and women. , Prevention and treatment of CAD focuses on
lifestyle changes, control of modifiable risk factors, medication and
percutaneous or surgical revascularization.
Percutaneous transluminal coronary angioplasty (PTCA) has historically been
used in addition to other treatment modalities in patients with symptomatic
CAD. However, there are major limitations to using PTCA as a standalone
treatment, including the high incidence of intimal dissections, abrupt vessel
closure and restenosis. As a result, the standard treatment option for CAD has
expanded to include both bare-metal and drug-eluting coronary stents. Early
generations of bare-metal stents were constructed of a 316 low-carbon stainless
steel; however, newer models utilize CoCr alloys that have proven both stronger
and denser than the stainless steel stents. The increase in strength from the
CoCr alloys has allowed for thinner struts, thereby affording an increased
flexibility and deliverability without compromising radial strength or
radiopacity. Recent studies have indicated that the ability of the CoCr alloys
to provide thinner struts has yielded less angiographic and clinical restenosis
compared to the thicker-strut stainless steel stents. , , Despite the recent
advances in bare-metal technology, drug-eluting stents remain the more common
treatment choice for symptomatic CAD due to the advantages in reducing
long-term restenosis rates. However, the latest generation of bare-metal
stents is closing the gap when comparing target vessel revascularization and
bare-metal stents remain an important option for patients unable to follow
required dual antiplatelet therapy guidelines post stent implantation and
patients likely to undergo invasive surgeries following stent placement.
Study objective
The primary objective of this study is to demonstrate the clinical performance
of PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native
coronary arteries.
Study design
Prospective, non-randomized, multi-center, Investigational Device Exemption
(IDE) study performed in the United States, Canada and Europe with a minimum of
296 evaluable patients.
Intervention
Potential subjects will undergo CAD screening according to each investigative
site*s standard of care. The medical history of individuals with CAD who
qualify for a percutaneous coronary intervention (PCI) procedure will be
evaluated and compared to all initial enrollment criteria. Potential subjects
must have documented evidence of a positive functional ischemia study (e.g.
exercise treadmill test, thallium stress test, SPECT, stress echocardiogram or
cardiac CT) or documented evidence of stable or unstable angina pectoris to be
considered for the study.
Following confirmation of all initial enrollment criteria, potential study
subjects will proceed with routine laboratory assessments and a 12-lead
electrocardiogram (ECG) according to each site*s standard of care to ensure
suitability to undergo a PCI procedure. The testing results will then be
compared to the relevant procedure-related eligibility criteria and, if within
acceptable limits, the subject will provide written informed consent for
enrollment in the study. For any routine, pre-procedure testing that is
outside of protocol requirements, subject informed consent will be obtained and
these tests performed according to the protocol. Written informed consent may
be obtained on the day of the index procedure (prior to any study-related
procedures) or within 30 days prior to the index procedure. Subjects whose
laboratory values and ECG analysis are acceptable (none within exclusion
criteria specifications) will continue to the index procedure for further
inclusion and exclusion criteria screening.
Prior to the placement of an investigational stent, a diagnostic angiogram will
be performed to characterize the lesion(s) and confirm the procedure-related
eligibility criteria. If the diagnostic angiogram reveals that the subject is
ineligible for the investigational stent implant based on the study eligibility
criteria, the subject will be considered a screen failure and exited from the
study. If the diagnostic angiogram confirms the procedure-related eligibility
criteria, but the subject experiences a complication from either pre-dilatation
of the target lesion or treatment of a non-target lesion (stent does not enter
the guide catheter), the subject will be considered a procedure failure and
exited from the study. However, if the investigational stent system enters the
guide catheter following the diagnostic angiogram, the subject will be
considered evaluable for the study endpoint analyses.
A final angiogram will be obtained immediately following the investigational
stent placement. Likewise, all evaluable subjects will have cardiac biomarker
levels assessed and a 12-lead ECG performed post-index procedure and prior to
hospital discharge.
All evaluable subjects will be followed for a total of 36 months post-index
procedure. The follow-up schedule will include an intermediate study visit at 1
month and a primary endpoint study visit at 9 months, with long-term study
visits at 12, 24 and 36 months. After the final study visit, the subject*s
participation in the study is complete. Each subject will be subsequently
followed per the investigative site*s standard of care.
Study burden and risks
The medical device in this study (i.e. PRO-Kinetic Energy) is a CE-marked
product being used within its approved indication for use. The patient will be
treated with the medical device regardless of his/her participation in this
study, thus the associated risks are the same if the patient did not
participate in the study. Patients will also be asked to provide additional
blood for follow-up cardiac biomarker tests at 6-12 hours and 18-24 hours after
the initial index procedure. All of the following follow-ups are clinical
follow-ups and do not involve invasive procedures. The benefit to the patient
is a close and detailed follow-up after the procedure as compared to when the
patient would not participate in the study.
Ackerstrasse 6
Bülach 8810
CH
Ackerstrasse 6
Bülach 8810
CH
Listed location countries
Age
Inclusion criteria
For a subject to be enrolled in the study and considered for the index procedure, the following initial inclusion criteria must be met:
* Age > or <= 18 years
* Willingness to comply with study follow-up requirements
* Candidate for a PCI procedure
* Candidate for coronary artery bypass graft surgery
* Documented evidence of stable or unstable angina pectoris or positive functional ischemia study (e.g. exercise treadmill test, thallium stress test, SPECT, stress echocardiogram or cardiac CT)
* Stable angina pectoris is defined as a documented Canadian Cardiovascular Society Classification of I, II, III or IV
* Unstable angina pectoris is defined as a documented Braunwald Classification of B & C, I, II, III
* Written informed consent
For a subject to receive an investigational stent, the following procedure-related criteria must be met:
* De novo or restenotic lesion in a native coronary artery; restenotic lesions must have been previously treated with only standard PTCA (treatment must be > 12 months prior to the index procedure)
* Target lesion must be in a major coronary artery (target vessel). The target vessel includes the entire territory of the left anterior descending artery, left circumflex artery or right coronary artery and any major side branch of the artery.
* A maximum of one target lesion and one non-target lesion may be treated per subject. The lesions must be located in separate coronary arteries, with treatment of the non-target lesion occurring first using commercially available therapy (with exception of brachytherapy).
* Lesions may be one solid lesion or a series of multiple, smaller lesions to be treated as one lesion
* Target lesion must be treatable with a single investigational stent; an additional stent may be used when treating a vessel dissection or another similar intra-procedure complication (use of investigational stent preferred)
* Angiographic evidence of * 50% and < 100% stenosis (by operator visual estimate) with a TIMI flow > 1
* Target lesion length of * 31 mm by operator visual estimate
* Target vessel reference diameter of 2.25 mm to 4.0 mm by operator visual estimate
Exclusion criteria
For a subject to be enrolled in the study and considered for the index procedure, the following initial exclusion criteria must not be present:
* Baseline LVEF of < 30%; LVEF may be measured and assessed by standard-of-care echocardiography procedures within 90 days of the index procedure or by a left ventriculogram prior to the index procedure (operator visual assessment)
* PCI in any vessel 30 days prior to the index procedure or planned for within 30 days after the index procedure
* Stroke or transient ischemic attack within the last 6 months prior to enrollment
* Intolerance to contrast agents that cannot be medically managed and/or intolerance to antiplatelet, anticoagulant or thrombolytic medications
* Refusal of blood transfusions
* Any other medical condition, that in the opinion of the investigator, poses an unacceptable risk for implant of a stent according to the study indications
* Pregnant, planning to become pregnant or nursing during the course of the study. Women of child-bearing potential must have a negative blood pregnancy (beta hCG) test. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.
* Known allergy to L-605 CoCr alloy (cobalt, chromium, tungsten and nickel) or amorphous silicon carbide
* Life expectancy of less than one year
* Participation in any other clinical investigational device or drug study. Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.;For a subject to receive an investigational stent the following procedure-related criteria must not be present:
* Documented diagnosis of an acute MI within 72 hours of the index procedure and an elevation of Troponin or CKMB above the URL (CKMB measurement is not required if CK is normal) at the time of the index procedure (99th percentile of the individual investigative site*s normal reference population)
* For subjects with stable angina and elevated Troponin, CKMB <99% URL is required
* ECG changes consistent with an acute MI within 72 hours of the index procedure. ECG changes consistent with an acute MI include:
* > 1 mm ST segment elevation or depression in consecutive leads
* New LBBB
* Development of pathological Q-waves in two contiguous leads of the ECG
* Acute coronary syndrome with baseline Troponin > 99% URL
* INR * 1.6
* Concomitant renal failure with serum creatinine level > 2.5 mg/dL
* Unresolved neutropenia (white blood cell count < 3,000 / µL), thrombocytopenia (platelet count < 100,000 / µL) or thrombocytosis (platelet count > 700,000 / µL)
* Unprotected left main CAD (> 50% diameter stenosis by operator visual estimate)
* Target vessel has been treated with any PCI procedure (e.g. PTCA, stent, cutting balloon, atherectomy, etc.) within 12 months prior to the index procedure
* Target lesion has been treated with a stent, cutting balloon or atherectomy any time prior to the index procedure or has been treated with PTCA within 12 months prior to the index procedure
* Target vessel treated with brachytherapy anytime prior to index procedure
* Planned PCI in the target vessel within 9 months after the index procedure
* Target vessel has a non-target lesion with a > 50% stenosis that requires treatment during the index procedure
* Lesions preventing distal perfusion (TIMI flow 0 and 1) prior to wire crossing
* Target lesion is in the left main coronary artery or within 2 mm of the origin of the left anterior descending artery or left circumflex artery by operator visual estimate
* Target lesion is located within a saphenous vein graft or arterial graft
* Target lesion involves a bifurcation * lesion is located in a major coronary artery and involves a side branch with a diameter > 2 mm (by operator visual estimate)
* Presence of a complication following pre-dilatation of target lesion
* Presence of a complication following treatment of a non-target lesion (if applicable)
* Presence of a target vessel/lesion that has excessive tortuousity/angulation or is severely calcified preventing complete inflation of an angioplasty balloon
* Angiographic evidence of thrombus within the target lesion
* Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion
* Use of cutting balloons, atherectomy or ablative devices immediately prior to investigational stent placement
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01612767 |
| CCMO | NL42680.060.12 |