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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04562805
Recruitment Status : Active, not recruiting
First Posted : September 24, 2020
Last Update Posted : September 7, 2023
Sponsor:
Collaborator:
Uppsala University
Information provided by (Responsible Party):
Elixir Medical Corporation

Study Description
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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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Ischemic Heart Disease Device: DynamX Bioadaptor Device: Resolute Onyx Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:

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.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2028
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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))


Secondary Outcome Measures :
  1. Device Success [ Time Frame: During Study Procedure ]
    Lesion-Level Analysis

  2. Procedural Success [ Time Frame: In-Hospital, assessed up to 7 days ]
    Patient-Level Analysis

  3. 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)

  4. 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.

  5. 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))

  6. 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

  7. 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)

  8. Rate of Target Lesion Revascularization (TLR) [ Time Frame: 30 days, 6 months, 1-5 years ]
    All Target Lesion Revascularization

  9. Rate of Target Vessel Revascularization (TVR) [ Time Frame: 30 days, 6 months, 1-5 years ]
    All Target Vessel Revascularization

  10. 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)

  11. 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)

  12. Rate of Non target vessel revascularization (NTVR) [ Time Frame: 30 days, 6 months, 1-5 years ]
    Non target vessel revascularization (NTVR)

  13. Rate of All revascularization [ Time Frame: 30 days, 6 months, 1-5 years ]
    All revascularization

  14. 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

  15. Rate of Death [ Time Frame: 30 days, 6 months, 1-5 years ]
    Cardiovascular Death, All-Cause Death

  16. Composite: Cardiovascular death or myocardial infarction [ Time Frame: 30 days, 6 months, 1-5 years ]
    Composite: Cardiovascular death or myocardial infarction

  17. Composite: All-cause death or myocardial infarction [ Time Frame: 30 days, 6 months, 1-5 years ]
    Composite: All-cause death or myocardial infarction

  18. 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

  19. Rate of any stroke [ Time Frame: 1 year and 5 years ]
    Any stroke (collected at 1 year and 5 years only)

  20. Anginal Status [ Time Frame: 30 days and 1 year ]
    Anginal Status by Seattle Angina Questionnaire-7 (SAQ-7)

  21. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 requiring rotablation or atherectomy
  • Bifurcation lesions requiring a planned 2 or more stent technique
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562805


Locations
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Sponsors and Collaborators
Elixir Medical Corporation
Uppsala University
Investigators
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Principal Investigator: David Erlinge, MD, PhD Skane University Hospital, Lund
Study Chair: Stefan James, MD, PhD Uppsala University
More Information
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Responsible Party: Elixir Medical Corporation
ClinicalTrials.gov Identifier: NCT04562805    
Other Study ID Numbers: ELX-CL-1806
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: September 7, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Coronary Disease
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases