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

October 15, 2024 updated by: Elixir Medical Corporation

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Eskilstuna, Sweden
        • Mälarsjukhuset Eskilstuna
      • Halmstad, Sweden
        • Hallands sjukhus
      • Helsingborg, Sweden
        • Helsingborgs Lasarett
      • Karlskrona, Sweden
        • Blekingesjukhuset i Karlskrona
      • Karlstad, Sweden
        • Centralsjukhuset Karlstad
      • Lund, Sweden
        • Skanes Universitetssjukhus I Lund
      • Malmö, Sweden
        • Skånes Universitetssjukhus i Malmö
      • Stockholm, Sweden
        • Karolinska Universitetssjukhuset Solna
      • Stockholm, Sweden
        • Danderyds Sjukhus
      • Stockholm, Sweden
        • Södersjukhuset
      • Stockholm, Sweden
        • Karolinska Universitetssjukhuset Huddinge
      • Stockholm, Sweden
        • Capio St Görans sjukhus
      • Sundsvall, Sweden
        • Sundsvall Hospital
      • Södra Sunderbyn, Sweden
        • Sunderby Sjukhus
      • Umeå, Sweden
        • Norrlands Universitetssjukhus Umeå
      • Uppsala, Sweden
        • Akademiska sjukhuset
      • Västerås, Sweden
        • Västmanlands sjukhus i Västerås
      • Örebro, Sweden
        • Universitetssjukhuset Örebro
      • Östersund, Sweden
        • Östersunds Sjukhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DynamX Bioadaptor
Elixir Medical DynamX™ Sirolimus Eluting Coronary Bioadaptor
Device: DynamX Bioadaptor
DynamX Bioadaptor Treatment
Active Comparator: Medtronic Resolute Onyx Stent
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Device: Resolute Onyx
Resolute Onyx Treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Target Lesion Failure (TLF)
Time Frame: 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device Success
Time Frame: During Study Procedure
Lesion-Level Analysis
During Study Procedure
Procedural Success
Time Frame: In-Hospital, assessed up to 7 days
Patient-Level Analysis
In-Hospital, assessed up to 7 days
Composite Rate of Device Oriented Clinical Endpoint (DOCE)
Time Frame: 30 days, 6 months, 1-5 years
Composite Device Oriented Clinical Endpoint (DOCE) (TLF; cardiovascular death, TV-MI, ischemia-driven TLR)
30 days, 6 months, 1-5 years
Composite Rate of Patient Oriented Clinical Endpoint (POCE)
Time Frame: 30 days, 6 months, 1-5 years
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.
30 days, 6 months, 1-5 years
Rate of Target Vessel Failure (TVF)
Time Frame: 30 days, 6 months, 1-5 years
Target vessel failure (TVF; cardiovascular death, target vessel myocardial infarction (TV-MI), or target vessel revascularization (TVR))
30 days, 6 months, 1-5 years
Composite Rate of cardiovascular death, any myocardial infarction and any revascularization
Time Frame: 30 days, 6 months, 1-5 years
Composite of cardiovascular death, any myocardial infarction and any revascularization
30 days, 6 months, 1-5 years
Rate of Ischemia driven target lesion revascularization (ID-TLR)
Time Frame: 30 days, 6 months, 1-5 years
Ischemia driven target lesion revascularization (ID-TLR)
30 days, 6 months, 1-5 years
Rate of Target Lesion Revascularization (TLR)
Time Frame: 30 days, 6 months, 1-5 years
All Target Lesion Revascularization
30 days, 6 months, 1-5 years
Rate of Target Vessel Revascularization (TVR)
Time Frame: 30 days, 6 months, 1-5 years
All Target Vessel Revascularization
30 days, 6 months, 1-5 years
Rate of Ischemia driven target vessel revascularization (ID-TVR)
Time Frame: 30 days, 6 months, 1-5 years
Ischemia driven target vessel revascularization (ID-TVR)
30 days, 6 months, 1-5 years
Rate of Ischemia driven non target vessel revascularization (ID-NTVR)
Time Frame: 30 days, 6 months, 1-5 years
Ischemia driven non target vessel revascularization (ID-NTVR)
30 days, 6 months, 1-5 years
Rate of Non target vessel revascularization (NTVR)
Time Frame: 30 days, 6 months, 1-5 years
Non target vessel revascularization (NTVR)
30 days, 6 months, 1-5 years
Rate of All revascularization
Time Frame: 30 days, 6 months, 1-5 years
All revascularization
30 days, 6 months, 1-5 years
Rate of Myocardial Infarction
Time Frame: 30 days, 6 months, 1-5 years
All MI, Q-Wave and Non Q-Wave MI, TV-MI, NTV-MI
30 days, 6 months, 1-5 years
Rate of Death
Time Frame: 30 days, 6 months, 1-5 years
Cardiovascular Death, All-Cause Death
30 days, 6 months, 1-5 years
Composite: Cardiovascular death or myocardial infarction
Time Frame: 30 days, 6 months, 1-5 years
Composite: Cardiovascular death or myocardial infarction
30 days, 6 months, 1-5 years
Composite: All-cause death or myocardial infarction
Time Frame: 30 days, 6 months, 1-5 years
Composite: All-cause death or myocardial infarction
30 days, 6 months, 1-5 years
Composite: All-cause death, myocardial infarction or target vessel revascularization
Time Frame: 30 days, 6 months, 1-5 years
Composite: All-cause death, myocardial infarction or target vessel revascularization
30 days, 6 months, 1-5 years
Rate of any stroke
Time Frame: 1 year and 5 years
Any stroke (collected at 1 year and 5 years only)
1 year and 5 years
Rate of Stent Thrombosis
Time Frame: 30 days, 6 months, 1-5 years
Composite: Probable or definite stent thrombosis Probable Stent Thrombosis Definite Stent Thrombosis
30 days, 6 months, 1-5 years
Landmark Analysis
Time Frame: 5 years or at the conclusion of the study
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
5 years or at the conclusion of the study
Anginal Status
Time Frame: 30 days, 1,3,4 and 5 years
Anginal Status by Seattle Angina Questionnaire-7 (SAQ-7)
30 days, 1,3,4 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elixir Medical Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Uppsala University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Erlinge, MD, PhD, Skåne University Hospital, Lund
  • Study Chair: Stefan James, MD, PhD, Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ELX-CL-1806

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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