This protocol will compare clinical outcomes of the SUPRAFLEX and XIENCE drug-eluting stents in a broad patient and lesion population and will gain substantial additional information on patients in a real world setting. These data will also provide…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint for this trial is a non-inferiority comparison of the
device-oriented composite endpoint Target Lesion Failure of the SUPRAFLEX group
to the XIENCE group at 12 months post-procedure. TLF (DoCE) is a composite of
clinical endpoint of cardiac death, target vessel myocardial infarction (TV-MI)
and clinically-indicated target lesion revascularization (TLR).
Secondary outcome
1. Composite Endpoints
a. Patient Oriented Composite Endpoint (PoCE) defined as all-cause death,
any MI, and any revascularization
b. Target Vessel Failure (TVF) defined as cardiac death, TV MI*, and
clinically indicated Target Vessel Revascularization
c. TLF (DoCE) defined as cardiac death, TV MI* and clinically-indicated
Target Lesion Revascularization (for all follow-up/visits other than 12 months)
2. Mortality
a. All death
b. Cardiac death
c. Non-cardiac death (vascular and non-cardiovascular)
3. Myocardial Infarction*
a. All MI
b.Target Vessel MI
c. Non-Target Vessel MI
4. Revascularization
a. Any revascularization
b.Target Lesion revascularization (TLR) (any, clinically-indicated TLR,
non-clinically indicated TLR)
c.Target Vessel revascularization (TVR) (any, clinically-indicated TVR,
non-clinically indicated TVR)
d.Non-Target Vessel revascularization
5. Stent thrombosis rates according to ARC classification
Background summary
One of the patient's coronary arteries has a significant narrowing that is
causing decreased blood flow to the heart muscle. To prevent damage to the
heart muscle, this narrowing has to be resolved. This is commonly done with a
percutaneous coronary intervention (PCI). The procedure is performed by
entering the arteries with a catheter through the groin or arm. By X-ray, the
coronary arteries are made visible. A balloon and then a stent are placed
within the narrowing in the artery to achieve the desired result; a reopened
artery with good blood flow. Stent placement means that a small metal scaffold
(stent) is left behind after the balloon is removed and the stent becomes a
permanent part of the artery. Stents have been used for many years to treat
narrowing of both coronary arteries. There are simple metal stents and drug
eluting stents (DES) In this trial 2 drug eluting stents will be used. The
procedure itself is a standard procedure for this condition.
Study objective
This protocol will compare clinical outcomes of the SUPRAFLEX and XIENCE
drug-eluting stents in a broad patient and lesion population and will gain
substantial additional information on patients in a real world setting. These
data will also provide data on various lesion types that may be treated in
order to expand the indications for the SUPRAFLEX Sirolimus Eluting Cobalt
Chromium Coronary Stent System.
Study design
This is a prospective, randomized, 1:1 balanced, controlled, single-blind,
multi-center study comparing clinical outcomes at 12 months between SUPRAFLEX
and XIENCE in a *Real world, all comers* patient population (patients with
symptomatic coronary artery disease including patients with chronic stable
angina, silent ischemia, and acute coronary syndromes, who qualify for
percutaneous coronary interventions). All patients will be (at minimum)
contacted at 30 days, 6 months, 12 months, 2 years and 3 years post procedure
to assess clinical status and adverse events. The 30 day and 12 month will be a
clinic visit.
Intervention
1430 patients will be enrolled to receive treatment with either the study
device (SUPRAFLEX) or a control device (XIENCE), in a 1:1 randomization (715
SUPRAFLEX and 715 XIENCE).
Study burden and risks
The potential risks and undesirable effects resulting from the use of these
stents are the same as for other stents. These are (but are not limited to):
death, stroke, heart attack, renewed narrowing of the coronary artery treated
with the stent or of another coronary artery, need for emergency bypass surgery
or repeat angioplasty. Undesirable events that may occur due to the procedure,
such as artery spasm, lack of oxygen for the heart, or damage to the coronary
artery, blood clots in the coronary artery or a side vessel, bleeding, for
example at the insertion site for the catheter, and the possible need for a
blood transfusion. Additionally, damage may occur to blood vessels from the
insertion site of the catheter towards the heart, infection and pain at the
catheter insertion site, heart arrhythmias that may be life-threatening, blood
pressure changes, allergy reactions to medicines, contrast medium or stent
materials.
Fortunately, serious complications are extremely rare, such as clot formation
in the arteries that can lead to a stroke or cerebral bleed. In general, a
complication is associated with the severity of the heart disease.
The potential risks for pregnancy associated with this treatment are unknown,
and use of adequate contraception during the course of the study is mandatory
for women of childbearing potential.
Westblaak 98
Rotterdam 3012KM
NL
Westblaak 98
Rotterdam 3012KM
NL
Listed location countries
Age
Inclusion criteria
1. Male or female patients >=18 years;
2. Presence of one or more coronary artery stenoses of >=50% in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation.
3. The vessel should have a reference vessel diameter ranging from >=2.25 mm to <=4.5 mm (no limitation on the number of treated lesions, vessels, or lesion length)
Exclusion criteria
1. Known pregnancy or breastfeeding at time of randomization;
2. Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor;
3. Any PCI treatment within 6 months (<6 months) prior to the index procedure.
4. Concurrent medical condition with a life expectancy of less than 12 months.
5. The patient is unwilling/not able to return for outpatient clinic at 1 month and 12 months follow-up.
6. Currently participating in another trial and not yet at its primary endpoint.
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 |
|---|---|
| CCMO | NL57788.018.16 |