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Active, not recruitingNCT04562805Updated Oct 16, 2024

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

An interventional study of DynamX Bioadaptor and Resolute Onyx in Coronary Artery Disease and Ischemic Heart Disease, sponsored by Elixir Medical Corporation. Active, not recruiting at 19 sites in Sweden. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-10-16.

Sponsored by Elixir Medical Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
2,400
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Coronary Artery Disease
  • Ischemic Heart Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 2,400 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Elixir Medical Corporation is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
2,400 participants (estimated)

Study arms

  • Experimental
    DynamX Bioadaptor

    Elixir Medical DynamX™ Sirolimus Eluting Coronary Bioadaptor

    Device: DynamX Bioadaptor

  • Active comparator
    Medtronic Resolute Onyx Stent

    Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

    Device: Resolute Onyx

Interventions

  • DeviceDynamX Bioadaptor

    DynamX Bioadaptor Treatment

  • DeviceResolute Onyx

    Resolute Onyx Treatment

06

What researchers measure

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))

    Time frame: 1 year

Secondary outcomes

  1. 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

  2. Device Success

    Lesion-Level Analysis

    Time frame: During Study Procedure

  3. Procedural Success

    Patient-Level Analysis

    Time frame: In-Hospital, assessed up to 7 days

  4. 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

  5. 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

  6. Rate of Target Vessel Failure (TVF)

    Target vessel failure (TVF; cardiovascular death, target vessel myocardial infarction (TV-MI), or target vessel revascularization (TVR))

    Time frame: 30 days, 6 months, 1-5 years

  7. 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

  8. 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

  9. Rate of Target Lesion Revascularization (TLR)

    All Target Lesion Revascularization

    Time frame: 30 days, 6 months, 1-5 years

  10. Rate of Target Vessel Revascularization (TVR)

    All Target Vessel Revascularization

    Time frame: 30 days, 6 months, 1-5 years

  11. 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

  12. 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

  13. Rate of Non target vessel revascularization (NTVR)

    Non target vessel revascularization (NTVR)

    Time frame: 30 days, 6 months, 1-5 years

  14. Rate of All revascularization

    All revascularization

    Time frame: 30 days, 6 months, 1-5 years

  15. 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

  16. Rate of Death

    Cardiovascular Death, All-Cause Death

    Time frame: 30 days, 6 months, 1-5 years

  17. Composite: Cardiovascular death or myocardial infarction

    Composite: Cardiovascular death or myocardial infarction

    Time frame: 30 days, 6 months, 1-5 years

  18. Composite: All-cause death or myocardial infarction

    Composite: All-cause death or myocardial infarction

    Time frame: 30 days, 6 months, 1-5 years

  19. 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

  20. Rate of any stroke

    Any stroke (collected at 1 year and 5 years only)

    Time frame: 1 year and 5 years

  21. Anginal Status

    Anginal Status by Seattle Angina Questionnaire-7 (SAQ-7)

    Time frame: 30 days, 1,3,4 and 5 years

  22. 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

07

Study locations

19 sites
  • 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
    Malmö, 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
  • Sunderby sjukhus
    Södra Sunderbyn, Sweden
  • Norrlands universitetssjukhus Umeå
    Umeå, Sweden
  • Akademiska Sjukhuset
    Uppsala, Sweden
  • Västmanlands sjukhus i Västerås
    Västerås, Sweden
  • Universitetssjukhuset Örebro
    Örebro, Sweden
  • Östersunds sjukhus
    Östersund, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04562805
Lead sponsor
Elixir Medical Corporation
Collaborators
Uppsala University
Responsible party
Sponsor
First posted
Sep 24, 2020
Start date
Sep 30, 2020
Primary completion
Sep 5, 2024
Completion
Jul 31, 2028 (estimated)
Last update
Oct 16, 2024

Study contacts

David Erlinge, MD, PhD
principal investigator · Skane University Hospital, Lund
Stefan James, MD, PhD
study chair · Uppsala University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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