The Infinity-Swedeheart trial is a prospective, multicenter, single-blind, randomized registry-based clinical trial. Eligible patients will be randomized 1:1 (DynamX Bioadaptor : Resolute Onyx).
The Infinity-Swedeheart trial is a prospective, multicenter, single-blind, randomized registry-based clinical trial. Eligible patients will be randomized 1:1 (DynamX Bioadaptor : Resolute Onyx). 2400 Patients will be randomized in Sweden. Patients will be followed at 30 days and 1 year by phone, and at 6 months and 2 to 5 years through clinical and diagnostic registries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,400
DynamX Bioadaptor Treatment
Resolute Onyx Treatment
Mälarsjukhuset Eskilstuna
Eskilstuna, Sweden
Hallands sjukhus
Halmstad, Sweden
Helsingborgs lasarett
Target Lesion Failure (TLF)
Device Oriented Clinical Endpoint (DOCE) of target lesion failure (TLF; cardiovascular death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR))
Time frame: 1 year
Landmark Analysis
DOCE from 6 Months to End of Follow-Up, DOCE of TVF from 6 Months to End of Follow-Up, DOCE from 6 Months to End of Follow-Up in subjects with ACS at Baseline
Time frame: 5 years or at the conclusion of the study
Device Success
Lesion-Level Analysis
Time frame: During Study Procedure
Procedural Success
Patient-Level Analysis
Time frame: In-Hospital, assessed up to 7 days
Composite Rate of Device Oriented Clinical Endpoint (DOCE)
Composite Device Oriented Clinical Endpoint (DOCE) (TLF; cardiovascular death, TV-MI, ischemia-driven TLR)
Time frame: 30 days, 6 months, 1-5 years
Composite Rate of Patient Oriented Clinical Endpoint (POCE)
Composite Patient Oriented Clinical Endpoint (POCE) (all-cause mortality, any stroke, any myocardial infarction (includes non-target vessel territory) and any revascularization). Note: Stroke to be collected and included in the POCE at 1 year and 5 years only.
Time frame: 30 days, 6 months, 1-5 years
Rate of Target Vessel Failure (TVF)
Target vessel failure (TVF; cardiovascular death, target vessel myocardial infarction (TV-MI), or target vessel revascularization (TVR))
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Helsingborg, Sweden
Blekingesjukhuset i Karlskrona
Karlskrona, Sweden
Centralsjukhuset Karlstad
Karlstad, Sweden
Skånes Universitetssjukhus i Lund
Lund, Sweden
Skånes Universitetssjukhus i Malmö
Malmö, Sweden
Universitetssjukhuset Örebro
Örebro, Sweden
Östersunds sjukhus
Östersund, Sweden
Sunderby sjukhus
Södra Sunderbyn, Sweden
...and 9 more locations
Time frame: 30 days, 6 months, 1-5 years
Composite Rate of cardiovascular death, any myocardial infarction and any revascularization
Composite of cardiovascular death, any myocardial infarction and any revascularization
Time frame: 30 days, 6 months, 1-5 years
Rate of Ischemia driven target lesion revascularization (ID-TLR)
Ischemia driven target lesion revascularization (ID-TLR)
Time frame: 30 days, 6 months, 1-5 years
Rate of Target Lesion Revascularization (TLR)
All Target Lesion Revascularization
Time frame: 30 days, 6 months, 1-5 years
Rate of Target Vessel Revascularization (TVR)
All Target Vessel Revascularization
Time frame: 30 days, 6 months, 1-5 years
Rate of Ischemia driven target vessel revascularization (ID-TVR)
Ischemia driven target vessel revascularization (ID-TVR)
Time frame: 30 days, 6 months, 1-5 years
Rate of Ischemia driven non target vessel revascularization (ID-NTVR)
Ischemia driven non target vessel revascularization (ID-NTVR)
Time frame: 30 days, 6 months, 1-5 years
Rate of Non target vessel revascularization (NTVR)
Non target vessel revascularization (NTVR)
Time frame: 30 days, 6 months, 1-5 years
Rate of All revascularization
All revascularization
Time frame: 30 days, 6 months, 1-5 years
Rate of Myocardial Infarction
All MI, Q-Wave and Non Q-Wave MI, TV-MI, NTV-MI
Time frame: 30 days, 6 months, 1-5 years
Rate of Death
Cardiovascular Death, All-Cause Death
Time frame: 30 days, 6 months, 1-5 years
Composite: Cardiovascular death or myocardial infarction
Composite: Cardiovascular death or myocardial infarction
Time frame: 30 days, 6 months, 1-5 years
Composite: All-cause death or myocardial infarction
Composite: All-cause death or myocardial infarction
Time frame: 30 days, 6 months, 1-5 years
Composite: All-cause death, myocardial infarction or target vessel revascularization
Composite: All-cause death, myocardial infarction or target vessel revascularization
Time frame: 30 days, 6 months, 1-5 years
Rate of any stroke
Any stroke (collected at 1 year and 5 years only)
Time frame: 1 year and 5 years
Anginal Status
Anginal Status by Seattle Angina Questionnaire-7 (SAQ-7)
Time frame: 30 days, 1,3,4 and 5 years
Rate of Stent Thrombosis
Composite: Probable or definite stent thrombosis Probable Stent Thrombosis Definite Stent Thrombosis
Time frame: 30 days, 6 months, 1-5 years