To compare OCT guided complete revascularization to the predefined objective performance goal (OPG) for all-cause death, stroke, myocardial infarction, or repeated revascularization namely 7% at 12 months. The OPG is derived from the most recent (9-…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is defined as the composite of death from any cause,
stroke, myocardial infarction, or repeat revascularization (MACCE) at 1-year
post index procedure, which was compared with a pre-specified objective
performance goal (OPG).
Secondary outcome
• Composite outcome of death from any cause, stroke, myocardial infarction, or
repeat revascularization (MACCE) at 30 days, 2 and 5
years post intervention.
• All-cause mortality at 30 days, 1, 2 and 5 years
• Myocardial Infarction at 30 days, 1, 2 and 5 years
• Any revascularization at 30 days, 1, 2 and 5 years
• Stroke at 30 days, 1, 2 and 5 years
• Major bleeding at 30 days and 12 months
• Need for renal replacement therapy at 30 days
• Feasibility on on-line complete functional assessment using FFRangio
Other study parameters:
Secondary imaging endpoint
• Minimal lumen diameter (QCA)
• Percent diameter stenosis (QCA)
• Acute lumen gain post-intervention (QCA)
• Maximum stent size/reference vessel diameter ratio (QCA)
• Angiographic Dissection >= NHLBI type B (QCA)
• Angiography-defined procedural success rate:
- Defined as a final lesion angiographic diameter stenosis <30%
(QCA) and TIMI III flow (QCA) without dissection >= NHLBI type C,
perforation, prolonged chest pain or ST segment elevation or
depression changes (>30 minutes), or procedural death.
• OCT device success rate (site reported):
- Successful OCT imaging obtained pre and post PCI
• Peri-procedural myocardial infarction according to the Society of
Cardiovascular Angiography and Intervention definition
• Post-PCI stent expansion (OCT):
- Defined as the minimum stent area divided by the average of
proximal and distal reference lumen areas x 100
• Untreated reference segment disease (OCT):
- Defined as untreated MLA <=60% of adjacent reference segment
lumen area up to 10 mm from the proximal and distal stent edges.
- Sub-classified by amount of untreated lipidic plaque, divided
into 3 grades:
A) Low (<= 90° of lipid arc)
B) Medium (>90°-<180° of lipid arc)
C) High (>=180° of lipid arc)
• Edge dissections (OCT):
- Major (%): >=60 degrees of the circumference of the vessel at
site of dissection and/or >=3 mm in length
- Minor (%): any visible edge dissection <60 degrees of the
circumference of the vessel and < 3 mm in length
- All (Major and Minor) (%)
• Edge dissections will be further classified as:
- Intimal (limited to the intima layer, i.e. not extending beyond
the internal elastic lamina)
- Medial (extending into the media layer)
- Adventitial (extending through the external elastic lamina)
• Stent malapposition (OCT):
- Frequency (%) of incompletely apposed stent struts (defined as
stent struts clearly separated from the vessel wall (lumen border/plaque
border) without any tissue behind the struts with a distance
from the adjacent intima of >=0.2 mm and not associated with any side
branch).
- Malapposition will be further classified as:
Major: If associated with stent underexpansion
(unacceptable stent expansion as defined above)
Minor: If not associated with significant
underexpansion (optimal or acceptable stent expansion as defined above)
Background summary
Previous studies comparing coronary artery bypass grafting (CABG) and
percutaneous coronary intervention (PCI) showed superiority of CABG over PCI in
patients with multivessel disease particularly driven by a higher need for
repeat revascularizations. Incomplete revascularization has been associated
with a higher rate of events and the presence of a chronic total occlusion has
been demonstrated as to be the most important independent predictor of
incomplete revascularization in patients with multivessel disease. The present
study aims at investigating the clinical results of complete revascularization
(complete revascularization of all significant lesion in vessels >= 2.5 mm and
in any case residual syntax score <6). Imaging (OCT) optimization should be
performed at least for the left anterior descending artery. FFR guidance will
be at operator discretion and should be performed according to current
guidelines. Guidance by a complete 3D-QCA based pre procedural functional
assessment (FFRangio) might be considered
Study objective
To compare OCT guided complete revascularization to the predefined objective
performance goal (OPG) for all-cause death, stroke, myocardial infarction, or
repeated revascularization namely 7% at 12 months. The OPG is derived from the
most recent (9-11-2021) publication of the FAME-III trial.
Study design
Prospective, multicenter, non-randomized, single arm, objective performance
goal study.
Intervention
Patients will be treated in a single arm fashion with:
• Complete revascularization with PCI in all vessels >= 2.5 mm with >=70%
stenosis by visual estimation or positive functional assessment and residual
syntax score <6.
• At least proximal and mid LAD lesions will be treated with optical coherence
tomography (OCT) guided PCI. OCT guided PCI for every lesion is encouraged if
feasible.
• Complete functional assessment with online 3D-QCA based fractional flow
reserve (FFRangio) ) to assess the hemodynamic relevance of intermediate-grade
lesions (40-90% diameter stenosis) could be considered as per operator
discretion and availability
Study burden and risks
Participation contributes to expansion of the knowledge base with respect to
best treatment of patients presenting with an SCAD or NSTE-ACS and more than
one narrowed artery, without CTO which may assist physicians in their choice of
treating any future patients. When participating in this study, the patient
will have more medical check-ups than when he/she would not be participating in
the study. In addition, he/she will be treated with a stent that was developed
with the latest technology.
Patients will be implanted with two or more Resolute Onyx DES,
Zotarolimus-Eluting stent systems. This stent model is approved to be used.
Therefore, there is no higher risk associated with implantation of these
systems in this study. The risk associated with stent implantation in general
is among others dependent on the severity of the narrowing(s) in the coronary
arteries, symptoms but also other factors.
For this study data from patients medical files will be gathered. There will be
no additional tests as compared to normal procedures.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
1. Age >= 18 years, <=85 years
2. The patient is an acceptable candidate for treatment with a drug eluting
stent in accordance with the applicable guidelines on percutaneous coronary
interventions, manufacturer*s Instructions for Use and the Declaration of
Helsinki
3. Patient indication, lesion length and vessel diameter of the target
lesion(s) are according to the *Instructions for Use* that comes with every
Resolute Onyx (Zotarolimus-Eluting stent) system.
4. The patient is willing and able to cooperate with study procedures and
required follow up visits
5. The subject or legal representative has been informed of the nature of the
study and agrees to its provisions and has provided an EC approved written
informed consent, including data privacy authorization
Exclusion criteria
1. Age <18 years and > 85 years.
2. Single coronary vessel disease.
3. No left anterior descending lesion.
4. Patients in cardiogenic shock.
5. Patients with STEMI.
6. Presence of a chronic total occlusion (CTO) defined as coronary lesion with
Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 on initial
angiography present for more than or equal to 3 months.
7. Left main coronary artery disease
8. Patients who cannot give informed consent or have a life expectancy of less
than 12 months.
9. Absolute contraindications or allergy that cannot be pre-medicated, to
iodinated contrast or to any of the study medications, including both aspirin
and P2Y12 inhibitors.
10. Patients with an extreme LAD tortuosity imparing OCT catheter advancement
11. Enrollment in another study with another investigational device or drug
trial that has not reached the primary endpoint . The patient may only be
enrolled once in the PRESENT study.
12. Previous coronary artery bypass grafting (CABG).
13. Patient requiring additional cardiac surgery within 6 months.
14. Women of childbearing potential who do not have a negative pregnancy test
result within 7 days before the procedure, women who are known to be pregnant,
or who are breastfeeding.
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 | NL76556.078.21 |