Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)

Elixir Medical

Status: Active, not recruiting

Conditions: Ischemic Heart Disease; Coronary Artery Disease

Treatments: Device: Resolute Onyx; Device: DynamX Bioadaptor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04562805

ELX-CL-1806

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,400 participants in 2 patient groups

DynamX Bioadaptor

Experimental group

Description:

Elixir Medical DynamX™ Sirolimus Eluting Coronary Bioadaptor

Treatment:

Device: DynamX Bioadaptor

Medtronic Resolute Onyx Stent

Active Comparator group

Description:

Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Treatment:

Device: Resolute Onyx