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

NCT ID: NCT04562805

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2028-07-31

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.

Conditions

Coronary Artery Disease; Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DynamX Bioadaptor

Elixir Medical DynamX™ Sirolimus Eluting Coronary Bioadaptor

Group Type: EXPERIMENTAL

DynamX Bioadaptor

Intervention Type: DEVICE

DynamX Bioadaptor Treatment

Medtronic Resolute Onyx Stent

Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Group Type: ACTIVE_COMPARATOR

Resolute Onyx

Intervention Type: DEVICE

Resolute Onyx Treatment

Interventions

DynamX Bioadaptor

DynamX Bioadaptor Treatment

Intervention Type: DEVICE

Resolute Onyx

Resolute Onyx Treatment

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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%.

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.)

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

Elixir Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Erlinge, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Skane University Hospital, Lund

Stefan James, MD, PhD

Role: STUDY_CHAIR

Uppsala University

Locations

Mälarsjukhuset Eskilstuna

Eskilstuna, , Sweden

Hallands sjukhus

Halmstad, , Sweden

Helsingborgs lasarett

Helsingborg, , Sweden

Blekingesjukhuset i Karlskrona

Karlskrona, , Sweden

Centralsjukhuset Karlstad

Karlstad, , Sweden

Skånes Universitetssjukhus i Lund

Lund, , Sweden

Skånes Universitetssjukhus i Malmö

Malmo, , Sweden

Universitetssjukhuset Örebro

Örebro, , Sweden

Östersunds sjukhus

Östersund, , Sweden

Sunderby sjukhus

Södra Sunderbyn, , Sweden

Capio St Görans sjukhus

Stockholm, , Sweden

Danderyds sjukhus

Stockholm, , Sweden

Karolinska Universitetssjukhuset Huddinge

Stockholm, , Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, , Sweden

Södersjukhuset

Stockholm, , Sweden

Sundsvall Hospital

Sundsvall, , Sweden

Norrlands universitetssjukhus Umeå

Umeå, , Sweden

Akademiska Sjukhuset

Uppsala, , Sweden

Västmanlands sjukhus i Västerås

Västerås, , Sweden

Countries

Sweden

References

Erlinge D, Andersson J, Frobert O, Tornerud M, Hamid M, Kellerth T, Grimfjard P, Winnberg O, Jurga J, Wagner H, Zwackman S, Adielsson M, Alstrom P, Masoe E, Ulvenstam A, Millgard J, Bohm F, Held C, Renlund H, Oldgren J, Smits PC, Elek C, Abizaid A, James S. Bioadaptor implant versus contemporary drug-eluting stent in percutaneous coronary interventions in Sweden (INFINITY-SWEDEHEART): a single-blind, non-inferiority, registry-based, randomised controlled trial. Lancet. 2024 Nov 2;404(10464):1750-1759. doi: 10.1016/S0140-6736(24)02227-X. Epub 2024 Oct 28.

Reference Type: DERIVED

PMID: 39481425 (View on PubMed)

Other Identifiers

ELX-CL-1806

Identifier Type: -

Identifier Source: org_study_id