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
In-stent late lumen loss at 9 months.
Secondary outcome
Event rates will be estimated for the following endpoints at 1, 9 and 12 months
post-index procedure unless otherwise noted:
• Target vessel failure (TVF) rate
• Individual components of the TVF rate (cardiac death, myocardial infarction
(MI), ischemia-driven target vessel revascularization (TVR))
• Overall TVR rate
• TLF rate, including individual components of the target lesion failure (TLF)
rate (cardiac death, myocardial infarction, ischemia-driven TLR)
• Overall TLR rate
• Rate of all cause mortality and all cause MI, including individual components
• Stent thrombosis rate
• Procedure success
• Device success
• Lesion success
• Angina pectoris classification
• Rates for individual adverse events
Background summary
Percutaneous transluminal coronary angioplasty (PTCA) has historically been
used in addition to other treatment modalities in patients with symptomatic
coronary artery disease (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. This study will be the first study to evaluate late lumen loss
angiographically after 9 months in patients with CAD treated with a CoCr bare
metal stent (i.e. PRO-Kinetic Energy) and therefore will provide essential
information regarding the use of CoCr bare metal stents.
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, study performed in Europe with a
minimum of 60 evaluable patients. A total of 80 patients will be enrolled to
compensate for a 25% drop-out rate.
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 including a negative
pregnanvy test for child bearing women, 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 12 months post-index
procedure. The follow-up schedule will include an intermediate study visit at 1
month and a follow-up angiogram at 9 months to assess the primary endpoint,
with a long-term study visit at 12 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 risks associated with this study are identical to the risks that would
occur if the subject was to receive the investigational coronary stent and not
participate in the study. These risks are listed in the Instructions for Use as
this product is a CE-marked product and approved for use in the Netherlands.
The patient is subjected to additional risks by performing the follow-up
angiogram 9-months after the procedure, but also gains the benefit of an
additional diagnostic test that could possibly detect a coronary lesion that
requires intervention. In addition, that subject will need to donate a small
amount of time for a follow-up at 1 and 12 months after the initial procedure
by participating in a telephone interview.
Ackerstrasse 6
Bülach 8180
CH
Ackerstrasse 6
Bülach 8180
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 * 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.
• 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
• Intolerance to contrast agents that cannot be medically managed and/or intolerance to antiplatelet, anticoagulant or thrombolytic medications
• 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:
• Concomitant renal failure with serum creatinine level > 2.5 mg/dL
• Unprotected left main CAD (> 50% diameter stenosis by operator visual estimate)
• 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 and is <15 mm apart from target lesion
• 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 | NCT01811927 |
| CCMO | NL42602.100.12 |