The study objective is to assess the safety and efficacy of the Permanent Polymer Zotarolimus-Eluting Stent Resolute Integrity* to the Polymer Free Amphilimus-Eluting Stent Cre8* compared in an all-comer patient population. 1 month of dual…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be evaluated at 12 months of follow up post-procedure:
* Target-Lesion Failure (TLF), consisting of: cardiac death, Target-Vessel
Myocardial Infarction (QWMI and NQWMI), or Target-Lesion revascularization
Revascularization by CABG or PCI
Secondary outcome
Net Adverse Clinical Events (NACE) defined as composite of: any death,
myocardial infarction, stroke, any unplanned repeated revascularization and
bleeding (BARC 3a and above), and separate components of the endpoints at 12-
months post-procedure:
* Target-Vessel revascularization by CABG or PCI (TVR)
* Stent thrombosis
* Device-, lesion-, and procedure success at time of baseline procedure
Background summary
Could possible reduce the antiplatelet duration period with a new generation
stent after PCI, retaining efficacy regarding restenosis etc.
Study objective
The study objective is to assess the safety and efficacy of the Permanent
Polymer Zotarolimus-Eluting Stent Resolute Integrity* to the Polymer Free
Amphilimus-Eluting Stent Cre8* compared in an all-comer patient population. 1
month of dual antiplatelet duration will be applied in stable angina pectoris
patients. Myocardial infarction patient population will be treated with 12
months of dual antiplatelet therapy.
Study design
A Prospective, Single-Center, Open Label, Randomized Controlled, two-arm Study
to Evaluate the Safety and Efficacy of the Permanent Polymer Zotarolimus
Eluting Stent *Resolute Integrity** Compared to Polymer Free Amphilimus Eluting
Stent *Cre8* .Dual Antiplatelet Therapy duration of 1 Month will be applied in
stable angina pectoris patient population. Myocardial infarction patient
population will be treated with 12 months of dual antiplatelet therapy (DAPT).
For the primary endpoint of 12-month TLF randomizing 525 patients 1:1 to
Amphilimus-eluting stent Cre8TM and zotarolimus-eluting stent Resolute
IntegrityTM affords at least 80% power to show clinical non-inferioirty,
assuming a TLF rate of 5.5% in both arms, and using a 1-sided binomial test of
proportions with a significance level of *=0.05, and a non-inferioirty margin
of 3.5%.
For the secondary endpoint of 12-months NACE, randomizing 1486 subjects 1:1 to
Amphilimus-eluting stent Cre8TM and zotarolimus-eluting stent Resolute
IntegrityTM affords at least 80% power to show non-inferioirty, assuming a NACE
rate of 8% in both arms, and using a 1-sided binomial test of proportions with
a significance level of *=0.05, and a non-inferioirty margin of 3.5%.
To ensure a sufficient level of power for the secondary endpoint and to account
for possible uncertainty regarding the estimated event rate of the primary
endpoint, the lager sample size of 1486 subjects was considered preferable.
Hence, One thousand five hundred thirty-two (1532) patients (1:1 randomization
Cre8 stent:Resolute Integrity* stent) will be enrolled in the study, with
clinical follow-up at 12 months to assess the primary end point.
After a period of 12 months, a clinical registry will be implemented
Information will be collected at 3-years post procedure.
Intervention
The *Cre8** stent is a polymer-free stent with a thin (80-µm) cobalt-chromium
alloy L605, integrally coated by an ultra-thin (0.3-µm) passive carbon coating
(i-Carbofilm, CID, Saluggia, Italy). The amphilimus formulation, constituted by
sirolimus (0.9 µg/mm2) formulated with an excipient composed of long-chain
fatty acids mixture, to modulate the drug (Sirolimus) release, is loaded into
abluminal reservoirs to obtain a targeted elution toward the vessel wall.
The *Resolute Integrity** stent, made from advanced cobalt alloy, is a
permanent-polymer stent with a BioLink biocompatible polymer, which allows
rapid, complete and functional healing. The polymer is a drug vehicle to
Zotarolimus, a potent antiproliferative drug, which allows effective inhibition
of neointimal growth.
Study burden and risks
This study carries no additional burden to the subject as daily clinical
practice (regarding site visits, blood samples, physical examination and other
tests) will be applied.
The risk associated with study participation is moderate.
Expected benefits are associated with lower bleeding complications associated
with lower DAPT duration
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
General Inclusion Criteria
a. All-comer patients 18 years and older;
b. Patient has been informed of the nature of the trial and agrees to its
provisions and has provided either oral during emergency procedure, followed by
written informed consent, or written informed consent in case of an elective
procedure as approved by the Medical Research Ethics Committee (MREC)
c. Patient is eligible for percutaneous coronary intervention (PCI) with
implantation of a drug-eluting stent
d. Patient has clinical evidence of ischemic heart disease, stable or unstable
angina, NSTEMI or STEMI, silent ischemia, or a positive functional
studyAngiographic Criteria
a. All de-novo and restenotic lesions (whether native coronary or bypass graft)
not amenable for treatment with drug eluting balloons
b. All lesions types are allowed: calcified lesions (lesion preparation with
scoring/cutting and rotational atherectomy is allowed), thrombus, chronic total
occlusion (CTO; randomized after successful wire crossing and pre-dilatation),
bifurcation lesions, ostial lesions and left main.
c. There is no limit for lesion length, or number of lesions or diseased
vessels.
d. Target vessel reference size (visual estimation) between 2.5 and 4.5
mmumwaar
Exclusion criteria
Exclusion Criteria
a. Inability to provide informed consent
b. Participation in another study for intracoronary stents that had not reached
its primary endpoint
c. Planned surgery within the next 3 months
d. Known intolerance to P2Y12 receptor antagonist that would prevent adherence
to DAPT, or intolerance to aspirin, Clopidogrel, Ticagrelor, Prasugrel,
Heparin/Bivalirudin, contrast agent (that cannot be adequately premedicated) or
component of drug-eluting stents
e. Female of childbearing potential, who are pregnant or are planning to become
pregnant
f. Life expectancy of less than 12 months
g.Patients undergoing revascularization prior to planned TAVI procedure
Angiographic Criteria:
a. Lesions amenable for treatment with drug eluting balloons
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 | NL48472.041.14 |