This scientific study is intended to compare the safety and effectiveness of two stents, the Firehawk* stent and the XIENCE* stent. Both stents release a medicine. This reduces the odds of the blood vessel narrowing again. The Firehawk* stent is…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the 12-month target lesion failure (TLF) rate, defined
as a composite of cardiac death, myocardial infarction (not clearly
attributable to a non-target vessel), or ischemia-driven revascularization of
the target lesion (ID-TLR) within 12 months.
Secondary outcome
Secondary endpoints:
Clinical endpoints measured in hospital and at 30 days, 3 months (OCT sub study
only), 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years:
* Target Lesion Revascularization (TLR) rate (ischemia-driven TLR, and any TLR)
* Target Lesion Failure (TLF) rate (primary endpoint at 12 months)
* Target vessel revascularization (TVR) rate (ischemia-driven TVR, and any TVR)
* All revascularization rate
* Target Vessel Failure (TVF) rate (composite of cardiac death, any myocardial
infarction [MI] not clearly attributable to a non-target vessel, or any
ischemia-driven revascularization of the target vessel)
* MI (Q-wave and non*Q-wave) rate
* Target vessel MI
* Cardiac death rate
* Non-cardiac death rate
* All death rate
* Cardiac death or MI rate
* All death or MI rate
* All death/MI/TVR rate
* Stent thrombosis rates (by Academic Research Consortium [ARC] definitions)
Peri-procedural endpoints:
* Technical device success rate
* Clinical procedural success rate
Angiographic endpoints at 13-month (time window 12*14 months post index
procedure) measured by QCA:
* In-stent late loss (mm) (powered endpoint)
* In-stent and in-segment percent diameter stenosis (%DS)
* In-segment late loss (mm)
* In-stent and in-segment binary restenosis rate (%)
* In-stent and in-segment minimum lumen diameter (MLD)
Optical Coherence Tomography (OCT) endpoints at 3-month post-index procedure :
o Neointimal thickness (µm) (powered endpoint)
o Mean/Minimal Stent diameter/area (mm/mm2)
o Mean/Minimal Lumen diameter/area (mm/mm2)
o Lumen volume (mm3)
o Stent volume (mm3)
o Mean neointimal hyperplasia area/volume (mm2/mm3)
o In-stent neointimal hyperplasia volume obstruction (%)
o Percentage of incomplete apposed struts (%)
o Uncovered strut rate
o Malapposed strut rate
o Malapposed and uncovered strut rate
Background summary
One or more narrowings in one or more coronary arteries that are reducing
blood flow to the heart muscle. To prevent damage to your heart muscle, the
narrowing(s) must be treated. This is usually done via a procedure called
percutaneous angioplasty. To do so, a thin tube (catheter) is inserted into
your arteries via the groin or wrist. X-rays are then used to make the coronary
artery visible. First a balloon is placed in the narrowing in the coronary
artery to open the artery, and a small metal tube called a stent is left in
place to prop the artery open.
The stent that is placed remains in your body and becomes a permanent part of
the artery. Stents have been used for years to treat narrowing of coronary
arteries and are not unique to this study. The procedure itself is a standard
procedure for this condition.
Study objective
This scientific study is intended to compare the safety and effectiveness of
two stents, the Firehawk* stent and the XIENCE* stent. Both stents release a
medicine. This reduces the odds of the blood vessel narrowing again.
The Firehawk* stent is covered with a layer containing the medicine Rapamycin
along with a polymer to hold and release the drug. This layer, also called a
'polymer layer', is 100% biodegradable; after the drug is released, the polymer
is slowly absorbed by your body and disappears entirely from the stent.
The XIENCE* stent is covered with a thin layer of 'polymer' containing the
medicine Everolimus. This polymer layer is not biodegradable and remains on the
stent permanently.
There may be advantages to a stent with a biodegradable polymer, because it is
fully absorbed by your body and does not remain on the stent. The medicine is
only released for a limited time (up to 3 months for the Firehawk*).
Both stents have a CE mark (approval for use in patients from authorities) and
meet the applicable regulations within the European Union. This study is being
performed to prove both stents are equally good.
Study design
This is a European, prospective, multicenter, 1:1 randomized (Firehawk* to
Xience TM family EES), controlled, open-label, non-inferiority trial in a *Real-
world, all-comer* population.
Clinical follow-up will be required at 30 days, 6 months, 12 months, 2 years, 3
years, 4 years, and 5 years after the index procedure.
Subjects who are enrolled but who do not receive a study stent (i.e., the
XienceTM family EES control stent or the Firehawk* stent), will be followed
through 12 months only.
Sub studies:
Angiographic (QCA) sub study: the first 176 consecutive subjects who consent to
participate in the angiographic sub study will undergo angiographic follow-up
at 13 months. The QCA sub study will be executed in selected sites in United
Kingdom, France, Spain, Italy, Belgium, Netherlands, Poland, Denmark and
possibly other European countries.
Optical Coherence Tomography (OCT) sub study: the first 50 consecutive subjects
who consent to participate in the OCT sub study will undergo OCT assessment and
clinical follow-up at 3 months post index procedure. The OCT sub study will be
performed in 3-5 pre-selected sites.
Intervention
828 Subjects will receive the Firehawk stent and 828 subjects will receive the
Xience stent. Approximately 25 sites in Europe will participate.
Study burden and risks
The potential risks and undesirable effects resulting from the use of these
stents are the same as for other stents. The potential risks are not specific
for participation in this clinical research.
The potential risks for pregnancy associated with this treatment are unknown,
and use of adequate contraception during the first year of the study is
mandatory for women of childbearing potential.
Newton Road, Z.J. Hi-Tech Park 501
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Shanghai 201203
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Listed location countries
Age
Inclusion criteria
CI1. Subject must be at least 18 years of age
CI2. Subject understands the trial requirements and the treatment
procedures and provides written informed consent before any trial-specific tests or
procedures are performed
CI3. Subject is eligible for percutaneous coronary intervention (PCI)
CI4. Subject has symptomatic coronary artery disease or silent ischemia with objective evidence of ischemia, or acute coronary syndromes, and qualifies for PCI
CI5. Subject is willing to comply with all protocol-required follow-up evaluations;Angiographic inclusion criteria:
AI1. Subject has one or more coronary artery stenosis of *50% in a native coronary artery or in a saphenous or arterial bypass conduit with visually estimated reference vessel diameter (RVD) *2.25 mm and *4.0 mm
AI2. Coronary anatomy is likely to allow delivery of a study device to the target
lesions(s)
Exclusion criteria
CE1. Subject has a known allergy to contrast (that cannot be adequately pre-medicated)
and/or the trial stent system or protocol-required concomitant medications (e.g.,
cobalt chromium alloy, stainless steel, sirolimus, everolimus or structurally related
compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
CE2. Planned surgery within 6 months after the index procedure
CE3. Subject has one of the following (as assessed prior to the index procedure):
o Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 12 months.
o Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
o Planned procedure that may cause non-compliance with the protocol or confound data interpretation.
CE4. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood
transfusions
CE5. Subject is participating in another investigational drug or device clinical trial that
has not reached its primary endpoint, or that, in the opinion of the investigator, may cause non-compliance with the protocol or confound data interpretation.
CE6. Subject intends to participate in another investigational drug or device clinical trial
within 12 months after the index procedure
CE7. Subject 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)
CE8. Subject 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);Note: No restrictions are placed on the total number of treated lesions, treated vessels, lesion length, or number of stents implanted.
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 | NCT02520180 |
| CCMO | NL55050.029.15 |