Acute Coronary Syndrome (ACS), Bioresorbable Scaffold, Drug Coated Balloon, Percutaneous Coronary Intervention (PCI)
Conditions
Keywords
MULTI-CENTER, OPEN-LABEL, PROSPECTIVE, RANDOMIZED STUDY, LONG-TERM EFFICACY OF DCB TREATMENT WITH BAIL-OUT BRS, BRS TREATMENT, DE-NOVO NATIVE CORONARY ARTERY LESIONS, YOUNG PCI POPULATION
Brief summary
The goal of this study is to investigate the equivalence in early and long-term efficacy between the two "Leave nothing behind strategies" (Drug-Coated Baloon \[DCB\] strategy with bail-out BioResorbable Scaffold \[BRS\] versus BRS strategy) of de-novo native coronary artery lesions in a relatively young Percutaneous Coronary Intervention (PCI) population, to be more specific, Patients with Chronic Coronary Syndromes (CCS) and Acute Coronary Syndrome (ACS) (Non-ST-segment Elevation Myocardial Infarction \[NSTEMI\] and Unstable angina) between 18-68 years of age scheduled for PCI. The main questions aim to answer are: DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 12 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has noninferior angiographic in-segment net gain at 13 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 60 months compared to BRS strategy? Participants will be followed at: 1. st FU visit - 1 month (in hospital) 2. nd FU visit - 6 months (telephone) 3. rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint 4. th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy 5. th FU visit - 730 days±30 days (telephone call) - 2Y 6. th FU visit - 1095 days±30 days (telephone call) - 3Y 7. th FU visit - 1460 days±30 days (telephone call) - 4Y 8. th FU visit- 1825 days±30 days (telephone call) - 5Y
Detailed description
The Leave Nothing Behind Study is an is an investigator-initiated trial. The Primary efficacy endpoint is target-vessel failure (TVF), defined as the composite of cardiovascular death, target-vessel myocardial infarction or ischemia-driven target-vessel revascularization (TVR) at 12 months. Co-primary efficacy endpoint (angiographic substudy) is the in-segment net gain at 13 months. Investigators aim to enroll 2256 patients in the main study and 196 patients in the angiographic substudy.
Interventions
PROCEDUREAngioplasty with DCB (bail-out BRS)
Angioplasty starts with lesion preparation in both arms with a PTCA balloon catheter. The lesion is treated with the Mozec SEB through femoral or brachial artery. The DCB should be delivered to the target lesion within 120 seconds of insertion into the guide catheter. Under fluoroscopic visualization, the DCB is inflated at least 30 seconds (single inflation). If the results are insufficient, multiple inflation is permitted. If despite appropriate delivery and inflation of the DCB, the results remain insufficient bail-out BRS should be performed. Bail-out BRS is performed through femoral or brachial artery. After correct positioning, the BRS is deployed slowly, i.e. 10 seconds/atm up to 4 atm, then 5 seconds/atm up to nominal pressure or higher until desired expansion is obtained. After desired expansion obtained, pressure is maintained for 30 seconds before balloon deflation. After BRS implantation, Optical Coherence Tomography (OCT) is performed, if available.
PROCEDUREAngioplasty with BRS
Bail-out BRS is performed through femoral or brachial artery. BRS implantation is guided by OCT, if available. After correct positioning, the BRS is deployed slowly, i.e. 10 seconds/atm up to 4 atm, then 5 seconds/atm up to nominal pressure or higher until desired expansion is obtained. After desired expansion obtained, pressure is maintained for 30 seconds before balloon deflation. After BRS implantation, OCT is performed, if available.
Sponsors
Ceric Sàrl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥ 18 years ≤ 68 years * Single vessel or multivessel disease with low to moderate complex de-novo native coronary artery lesions up to 30 mm length and reference vessel diameter 2.75-4.0 mm * Maximum of 3 target lesions * Maximal cumulative lesion length of all treated lesions 80 mm * Signed informed consent for participation in the study
Exclusion criteria
* ST-segment Elevation Myocardial Infarction (STEMI) treatment at index or in the previous 48 hours * Severe calcified lesions * Bifurcations lesions with planned 2 device strategy * Left-Main (LM) disease ≥ 50% diameter stenosis * More than 3 target lesions * Renal insufficiency with Glomerular Filtration Rate (GFR) \< 45 ml/min * Life expectancy less than 1 year * Known hypersensitivity or allergy to aspirin or P2Y12 receptor inhibitors * Incapable of providing written informed consent * Pregnant or breastfeeding women * Under judicial protection, tutorship, or curatorship * Participation in another trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target-vessel Failure (TVF) | From enrollment to the end of treatment at 12 months | Target vessel failiure is defined as the composite of cardiovascular death, target-vessel myocardial infarction or ischemia-driven target-vessel revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target-Vessel Failure (TVF) at 2, 3, 4 and 5 years. | From enrollment to the end of treatment at every year from 2 years until 5 years follow-up | Target vessel failiure is defined as the composite of cardiovascular death, target-vessel myocardial infarction or ischemia-driven target-vessel revascularization |
| Target-Lesion Failure (TLF) | From enrollment to the end of treatment every year until end of 5 years | Target Lesion Failure is is defined as the composite of cardiac death, target vessel-related myocardial infarction (Q wave and non-Q wave) and ischemia-driven target lesion revascularization |
| (Bleeding Academic Research Consortium) BARC 2, 3 or 5 bleedings | From enrollment to the end of treatment every year until end of 5 years | BARC definitions Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3, type 4, or type 5 but does meet at least one of the following criteria: requiring nonsurgical, medical intervention by a health care professional; leading to hospitalization or increased level of care; or prompting evaluation. Type 3a: overt bleeding plus a hemoglobin drop of 3 to 5 g/dL\* ; any transfusion with overt bleeding. Type 3b: overt bleeding plus a hemoglobin drop of 5 g/dL ; cardiac tamponade; bleeding requiring surgical intervention for control ; bleeding requiring intravenous vasoactive agens. Type 3c: intracranial hemorrhage |
| Net Adverse Clinical Event (NACE) | From enrollment to the end of treatment every year until end of 5 years | NACE defined as all-cause death, myocardial infarction, all-stroke, ischemia driven TVR or BARC 3 or 5 bleeding |
Countries
Estonia
Contacts
CONTACTDAVIDE CAPODANNO, Professor
CONTACTCERC France
Outcome results
None listed