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

NCT04562805 | Active Not Recruiting DMC FDA Device

• 1 other identifier: ELX-CL-1806
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 19

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).

Conditions

Coronary Artery Disease; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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))

  1 year

Secondary Outcomes (22)

• Landmark Analysis

  5 years or at the conclusion of the study

• Device Success

  During Study Procedure

• Procedural Success

  In-Hospital, assessed up to 7 days

• Composite Rate of Device Oriented Clinical Endpoint (DOCE)

  30 days, 6 months, 1-5 years

• Composite Rate of Patient Oriented Clinical Endpoint (POCE)

  30 days, 6 months, 1-5 years

Study Arms (2)

DynamX Bioadaptor

EXPERIMENTAL

Elixir Medical DynamX™ Sirolimus Eluting Coronary Bioadaptor

Device: DynamX Bioadaptor

Medtronic Resolute Onyx Stent

ACTIVE COMPARATOR

Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Device: Resolute Onyx

Interventions

DynamX Bioadaptor DEVICE

DynamX Bioadaptor Treatment

DynamX Bioadaptor

Resolute Onyx DEVICE

Resolute Onyx Treatment

Medtronic Resolute Onyx Stent

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).
• 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.
• If a planned Non-Target Lesion is present it must have been treated without complication\* prior to randomization.
• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Elixir Medical Corporation: lead
• Uppsala University: collaborator

Study Sites (19)

Mälarsjukhuset Eskilstuna

Eskilstuna, Sweden

Location

Hallands sjukhus

Halmstad, Sweden

Location

Helsingborgs lasarett

Helsingborg, Sweden

Location

Blekingesjukhuset i Karlskrona

Karlskrona, Sweden

Location

Centralsjukhuset Karlstad

Karlstad, Sweden

Location

Skånes Universitetssjukhus i Lund

Lund, Sweden

Location

Skånes Universitetssjukhus i Malmö

Malmo, Sweden

Location

Universitetssjukhuset Örebro

Örebro, Sweden

Location

Östersunds sjukhus

Östersund, Sweden

Location

Sunderby sjukhus

Södra Sunderbyn, Sweden

Location

Capio St Görans sjukhus

Stockholm, Sweden

Location

Danderyds sjukhus

Stockholm, Sweden

Location

Karolinska Universitetssjukhuset Huddinge

Stockholm, Sweden

Location

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

Sundsvall Hospital

Sundsvall, Sweden

Location

Norrlands universitetssjukhus Umeå

Umeå, Sweden

Location

Akademiska Sjukhuset

Uppsala, Sweden

Location

Västmanlands sjukhus i Västerås

Västerås, Sweden

Location

Related Publications (1)

• 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.

  PMID: 39481425 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• David Erlinge, MD, PhD

  Skane University Hospital, Lund

  PRINCIPAL INVESTIGATOR

• Stefan James, MD, PhD

  Uppsala University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will be blinded to the assigned device from the point of randomization onward. Study site personnel will be trained not to disclose the treatment assignment to the patient. Site personnel assigned to conduct phone follow-up visits will be provided with a standard interview script in order to reduce bias. The Clinical Event Committee will be blinded to the fullest extent possible with only redacted source documents included in the event packages.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 24, 2020
• Study Start: September 30, 2020
• Primary Completion: September 5, 2024
• Study Completion (Estimated): July 31, 2028
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (19)