The primary objective of this study is to evaluate the target lesion failure rate of the Conor Sirolimus-eluting Coronary Stent System in lesions up to 28 mm in length in native coronary arteries with a reference vessel diameter of 2.5 mm to 3.5 mm…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is target lesion failure (TLF) defined as a
composite of clinically-driven target lesion revascularization, target vessel
related myocardial infarction, or cardiac death that could not be clearly
attributed to a vessel other than the target vessel at 12-months
post-procedure.
Secondary outcome
•Procedural endpoints: Lesion success, Device success, Procedure success.
•Clinical endpoints through 18 months post procedure and annually from 2 to 5
years post procedure: Target lesion revascularization (TLR) (total and
clinically driven), Target vessel revascularization (TVR) (total and clinically
driven), Target vessel failure (TVF) and its individual components, Major
adverse cardiac events (MACE) (death, Q wave or WHO-defined non-Q wave
myocardial infarction, emergent bypass surgery, or repeat target lesion
revascularization) and its individual components.
•Safety endpoints through 18 months post procedure and annually from 2 to 5
years post procedure: Stent thrombosis (acute, sub-acute, late, very late),
Bleeding events, Death (cardiac and non-cardiac), Myocardial Infarction (Q wave
or WHO-defined non-Q wave), Stroke (hemorrhagic and non- hemorrhagic).
•Patient reported outcomes as measured by a quality of life (QOL) survey at
baseline, 30 days, 6 months, 12 months, 18 months, and from 2-5 years post
procedure.
Background summary
Restenosis remains a frequent cause of late failure after initially successful
coronary angioplasty occurring in as many as 20-40% of procedures performed.
Restenosis following stenting is primarily a result of neointimal hyperplasia.
An increasing body of evidence has emerged demonstrating that local delivery of
pharmacologic agents that inhibit cellular proliferation, and therefore
neointimal hyperplasia, may lead to improved outcomes following coronary
stenting. The advantages of local drug delivery include sufficient drug
concentration in the treated segment while limiting systemic exposure and
potential side effects.
The first agents to be studies for the prevention of coronary restenosis on a
drug-eluting stent platform were sirolimus and paclitaxel. Sirolimus has an
anti-proliferatieve action in T cells and smooth muscle cells and prevents
proliferation and migration of smooth muscle cells in several models of
restenosis and vascular disease.
Study objective
The primary objective of this study is to evaluate the target lesion failure
rate of the Conor Sirolimus-eluting Coronary Stent System in lesions up to 28
mm in length in native coronary arteries with a reference vessel diameter of
2.5 mm to 3.5 mm compared to an OPC derived from historical data.
Study design
The RES-Elution II NR study is a prospective, multi-center, single-arm,
open-label study for the treatment of
lesions in native coronary arteries. Clinical follow-up will take place at 30
days, 6 months, 12 months, 18 months
and annually from 2 through 5 years post-procedure.
Intervention
Standard procedure of balloon angioplasty with stenting procedure and
con-comitant anti-platelets treatment.
Study burden and risks
The following risks relating to standard PTCA, stenting, and angiography may
occur (listed in order of severity): Death; intima dissection (additional stent
placing or surgical revascularisation), injury to the artery requiring
emergency coronary artery bypass graft; Myocardial ischemia and/or infarction;
Stroke/transient ischemic attack; Cardiac tamponade, Dissection, perforation,
or rupture of the coronary artery; Embolism; Stent thrombosis/occlusion (early
or late); Total occlusion of the artery; Restenosis of the stented artery;
Coronary perforation; Aneurysm, pseudoaneurysm, or arteriovenous fistula;
Arrhythmias including tachyarrhythmias, bradyarrhythmias or cardiac arrest;
Hemorrhage, possibly requiring transfusion, as a result of the procedure or
associated medications; Renal insufficiency or renal failure; Respiratory
failure; Shock/pulmonary edema; Abrupt vessel closure or spasm;
Hypotension/hypertension; Allergic reaction or hypersensitivity (to contrast,
antiplatelet therapy, stent materials including metal, drug or polymers);
Peripheral ischemia/peripheral nerve injury; Infection or fever; Unstable
angina; atypical angina; chest pain; Pain/reaction at catheter insertion site;
balloon rupture; Stent migration; Failure to deliver the stent to the intended
site of treatment; Stent misplacement; Incomplete stent apposition; Stent
compression; Stent fracture; Vasospasm; Hematoma. Deformed stents that cannot
be implanted could also lead to problems associated with stent retrieval which
could in turn expose the patient to longer procedure times and increased x-ray
exposure.
Potential adverse events not outlined above but listed in the CYPHER® SELECT
Plus and/or CYPHER® product labeling (Cordis Corporation) P020026 that may be
related to sirolimus or to the sirolimus drug coating include: Immune
suppression, especially in patients with hepatic insufficiency or who are
taking medications that inhibit CYP3A4 or P-glycoprotein; Hypersensitivity, to
the drug (sirolimus or its excipients) or to the polymer (or individual
components) including anaphylactic/anaphylactoid type reactions; Changes in
lipid metabolism which may include hypertriglyceridemia or
hypercholesterolemia; Abnormal liver function tests; Anemia, low white blood
cell count, or low platelet count; Joint pain/discomfort; Diarrhea; Increased
cholesterol or increased triglycerides; Low blood potassium levels; Infections;
Interstitial lung disease; Lymphoma and other malignancies.
The bruden for the patient exists of ballon angioplasty with stenting procedure
and anticoagulant therapy.
The patient will be admitted to the hospital for the ballon angioplasty with
stenting procedure for 1-2 days.
Clinical follow-up will take place at 30 days, 6 months, 12 months, 18 months
and annually from 2 through 5 years post-procedure. During this visits patient
will be asked to complete a QoL questionnaire, ECG will be taken and the
investigator will assess the patient's angina status. After 6 months an
identical telephone visit will be done without the ECG.
1003 Hamilton Court
Menlo Park, CA 94025
United States of America
1003 Hamilton Court
Menlo Park, CA 94025
United States of America
Listed location countries
Age
Inclusion criteria
Inclusion Criteria:;-1 Subjects with atherosclerotic CAD ;
-2 The subject must be >/= 18 years of age;
-3 Diagnosis of angina pectoris as defined by stable angina pectoris Canadian Cardiovascular Society Classification (Class I, II, III) OR non-ST segment elevation acute coronary syndrome (Braunwald Classification B&C) OR OR non-ST segment elevation myocardial infarction >= 48 hours from the time of study index procedure OR asymptomatic subjects with a positive stress test;
-4 Indicated treatment of up to two lesions in one or two major coronary arteries (1 target lesion in each of 2 vessels or 2 target lesions in 1 vessel). The target vessel diameter must be >/= 2.25mm and -5 Target lesion length -6 The target lesion has been successfully crossed with the intracoronary guidewire which is positioned intraluminally in the distal vessel;
-7 The target lesion diameter stenosis is >50% and <100% based on a visual estimate.
Exclusion criteria
Exclusion Criteria:;-1 ST-elevation MI within 72 hours prior to the index procedure and/or creatine kinase (CK) >2 times the local laboratory upper limits of normal on the day of the index procedure;
-2 The patient has undergone target vessel revascularization within 6 months prior to the intended enrolment procedure.
-3 Prior stent within 5 mm of target lesion(s);
-4 Ostial target lesion(s);
-5 Unprotected left main coronary disease with >/= 50% stenosis;
-6 Angiographic evidence of thrombus within target lesion(s);
-7 Total coronary occlusion or TIMI grade 0 or 1 in the target vessel;
-8 Bifurcation disease involving a side branch >/= 2 mm in diameter;
-9 Target lesion(s) within a coronary bypass graft;
-10 Significant calcification or angulation in the target vessel that, in the Investigator's opinion, may preclude stent delivery and deployment;
-11 Recipient of heart transplant;
-12 Subject with a life expectancy less than 12 months;
-13 Known allergies to the following: aspirin, any thienopyridine, heparin, cobalt chromium, contrast agent (that cannot be managed medically), or sirolimus that cannot be managed medically;
-14 The patient has contraindication to ASA or to any thienopyridine agent.
-15 Known bleeding or hypercoagulable disorder;
-16 Known or suspected active infection at the time of the study procedures;
-17 Subject has had major surgical or interventional procedures unrelated to this study within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study, or planned coronary PCI through the end of the study;
-18 The patient is currently taking systemic immunosuppressant therapy;
-19 Documented left ventricular ejection fraction (EF) < 25%;
-20 Impaired renal function (creatinine > 250 micromoles/l or > 2.5 mg/dl) at the time of treatment.
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 | NCT00714883 |
| CCMO | NL24567.101.08 |