Clinical trial NCT04562805: Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)
Official title: Infinity-Swedeheart Study: Registry Based Randomized Clinical Trial (R-RCT) Comparing Long Term Outcomes of the DynamX Bioadaptor to the Resolute Onyx Stent in a More-comer PCI Patient Population
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Lead sponsor: Elixir Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Uppsala University
First posted: 2020-09-24
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: General Inclusion Criteria:

* Patient age ≥ 18 and ≤ 85 years
* Patient understands the trial requirements and treatment procedures and provides informed consent prior to any trial-specific tests or treatment
* Patients with CCS (stable angina, chronic angina, and chronic coronary artery disease) or ACS (unstable angina, ST-elevated myocardial infarction, and non-ST-elevated myocardial infarction) indicated for a percutaneous intervention with stent implantation.

Angiographic Inclusion Criteria:

* Patient has ≤ 3 lesions planned to be treated during the index procedure, each in a native epicardial vessel (including up to 1 planned Non-Target Lesion).

  1. Treatment is limited to a maximum of 2 Target Lesions per epicardial vessel. Any planned Non-Target Lesion must be located in a separate vessel from Target Lesion(s).
  2. When treatment of 2 target lesions in a single epicardial vessel is planned, there must be adequate separation between lesions to ensure a gap of greater than or equal to 10 mm between study devices.
  3. If a planned Non-Target Lesion is present it must have been treated without complication\* prior to randomization.
  4. The definition of epicardial vessels is the LAD, LCx and RCA, and is inclusive of their branches.
* Target Lesion vessel diameter(s) and lesion length(s) suitable for implantation with either study device (DynamX Bioadaptor or Control) using a single device per lesion.
* Successful pre-dilatation of a minimum of 1 Target Lesion, defined as no waist in the inflated pre-dilatation balloon (using two orthogonal views) with a pre-dilatation balloon diameter size approximately 0.25 mm smaller than reference vessel diameter but not more than 0.5 mm smaller than the reference vessel diameter. A residual diameter stenosis prior to study device implantation by visual estimate is recommended to be \< 30%.

General Exclusion Criteria:

* Acute myocardial infarction with Killip class III and IV
* Known history of chronic heart failure with LVEF \< 30%
* Life expectancy \< 2 years
* Patients on renal dialysis or with known eGFR \< 30 ml/min
* Planned surgery necessitating interruption of dual antiplatelet therapy within 6 months after the index procedure
* Known intolerance to components of the study device or control stent or medication required (e.g. intolerance to concomitant anticoagulation or antiplatelet therapy)
* Patient has a current diagnosis of active COVID-19 disease
* Patient is currently participating in another clinical trial with an investigational device or an investigational drug that has the potential to impact study results (such as, anti-thrombotic or anti-platelet medications) that has not yet completed its primary endpoint
* Known pregnancy or breastfeeding
* Patient is, in the opinion of the Investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason
* Subject has undergone prior PCI in a target vessel during the last 12 months. (A target lesion can be randomized and treated if a vessel contains a stent older than 12 months if the stent is more than 10 mm from the intended target lesion.)

Angiographic Exclusion Criteria:

* Lesions in the left main artery
* Venous or arterial bypass grafts
* In-stent restenosis
* Chronic total occlusion
* Ostial lesions (\< 3 mm of the ostium of the RCA, LAD or LCx)
* Prior stent located in a Non-Target Vessel \< 48 hours prior to the index procedure
* Lesion with severe calcification and/or tortuosity requiring the planned use of a guide extension catheter, rotablation or atherectomy
* Bifurcation lesions requiring a planned 2 or more stent technique

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 1 year
Secondary outcomes:
measure: Landmark Analysis
timeFrame: 5 years or at the conclusion of the study
measure: Device Success
timeFrame: During Study Procedure
measure: Procedural Success
timeFrame: In-Hospital, assessed up to 7 days
measure: Composite Rate of Device Oriented Clinical Endpoint (DOCE)
timeFrame: 30 days, 6 months, 1-5 years
measure: Composite Rate of Patient Oriented Clinical Endpoint (POCE)
timeFrame: 30 days, 6 months, 1-5 years
measure: Rate of Target Vessel Failure (TVF)
timeFrame: 30 days, 6 months, 1-5 years
measure: Composite Rate of cardiovascular death, any myocardial infarction and any revascularization
timeFrame: 30 days, 6 months, 1-5 years
measure: Rate of Ischemia driven target lesion revascularization (ID-TLR)
timeFrame: 30 days, 6 months, 1-5 years
measure: Rate of Target Lesion Revascularization (TLR)
timeFrame: 30 days, 6 months, 1-5 years
measure: Rate of Target Vessel Revascularization (TVR)
timeFrame: 30 days, 6 months, 1-5 years
measure: Rate of Ischemia driven target vessel revascularization (ID-TVR)
timeFrame: 30 days, 6 months, 1-5 years
measure: Rate of Ischemia driven non target vessel revascularization (ID-NTVR)
timeFrame: 30 days, 6 months, 1-5 years
measure: Rate of Non target vessel revascularization (NTVR)
timeFrame: 30 days, 6 months, 1-5 years
measure: Rate of All revascularization
timeFrame: 30 days, 6 months, 1-5 years
measure: Rate of Myocardial Infarction
timeFrame: 30 days, 6 months, 1-5 years
measure: Rate of Death
timeFrame: 30 days, 6 months, 1-5 years
measure: Composite: Cardiovascular death or myocardial infarction
timeFrame: 30 days, 6 months, 1-5 years
measure: Composite: All-cause death or myocardial infarction
timeFrame: 30 days, 6 months, 1-5 years
measure: Composite: All-cause death, myocardial infarction or target vessel revascularization
timeFrame: 30 days, 6 months, 1-5 years
measure: Rate of any stroke
timeFrame: 1 year and 5 years
measure: Anginal Status
timeFrame: 30 days, 1,3,4 and 5 years
measure: Rate of Stent Thrombosis
timeFrame: 30 days, 6 months, 1-5 years
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset Eskilstuna
city: Halmstad
country: Sweden
facility: Hallands sjukhus
city: Helsingborg
country: Sweden
facility: Helsingborgs lasarett
city: Karlskrona
country: Sweden
facility: Blekingesjukhuset i Karlskrona
city: Karlstad
country: Sweden
facility: Centralsjukhuset Karlstad
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus i Lund
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus i Malmö
city: Stockholm
country: Sweden
facility: Capio St Görans sjukhus
city: Stockholm
country: Sweden
facility: Danderyds sjukhus
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital
city: Södra Sunderbyn
country: Sweden
facility: Sunderby sjukhus
city: Umeå
country: Sweden
facility: Norrlands universitetssjukhus Umeå
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Västerås
country: Sweden
facility: Västmanlands sjukhus i Västerås
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
city: Östersund
country: Sweden
facility: Östersunds sjukhus
Study officials:
affiliation: Skane University Hospital, Lund
name: David Erlinge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Stefan James, MD, PhD
role: STUDY_CHAIR
References: