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

• ClinicalTrials.gov Identifier: NCT04562805
• Recruitment Status: Active, not recruiting
• First Posted: September 24, 2020
• Last Update Posted: September 7, 2023
• Sponsor: Elixir Medical Corporation
• Collaborator: Uppsala University
• Information provided by (Responsible Party): Elixir Medical Corporation

Tracking Information

• First Submitted Date: September 15, 2020
• First Posted Date: September 24, 2020
• Last Update Posted Date: September 7, 2023
• Actual Study Start Date: September 30, 2020
• Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 18, 2020)

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))

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 18, 2020)

• Device Success [ Time Frame: During Study Procedure ]
  Lesion-Level Analysis
• Procedural Success [ Time Frame: In-Hospital, assessed up to 7 days ]
  Patient-Level Analysis
• 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)
• 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.
• 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))
• 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
• 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)
• Rate of Target Lesion Revascularization (TLR) [ Time Frame: 30 days, 6 months, 1-5 years ]
  All Target Lesion Revascularization
• Rate of Target Vessel Revascularization (TVR) [ Time Frame: 30 days, 6 months, 1-5 years ]
  All Target Vessel Revascularization
• 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)
• 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)
• Rate of Non target vessel revascularization (NTVR) [ Time Frame: 30 days, 6 months, 1-5 years ]
  Non target vessel revascularization (NTVR)
• Rate of All revascularization [ Time Frame: 30 days, 6 months, 1-5 years ]
  All revascularization
• 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
• Rate of Death [ Time Frame: 30 days, 6 months, 1-5 years ]
  Cardiovascular Death, All-Cause Death
• Composite: Cardiovascular death or myocardial infarction [ Time Frame: 30 days, 6 months, 1-5 years ]
  Composite: Cardiovascular death or myocardial infarction
• Composite: All-cause death or myocardial infarction [ Time Frame: 30 days, 6 months, 1-5 years ]
  Composite: All-cause death or myocardial infarction
• 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
• Rate of any stroke [ Time Frame: 1 year and 5 years ]
  Any stroke (collected at 1 year and 5 years only)
• Anginal Status [ Time Frame: 30 days and 1 year ]
  Anginal Status by Seattle Angina Questionnaire-7 (SAQ-7)
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)
• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Coronary Artery Disease
• Ischemic Heart Disease

Intervention

• Device: DynamX Bioadaptor
  DynamX Bioadaptor Treatment
• Device: Resolute Onyx
  Resolute Onyx Treatment

Study Arms

• Experimental: DynamX Bioadaptor
  Elixir Medical DynamX™ Sirolimus Eluting Coronary Bioadaptor
  Intervention: Device: DynamX Bioadaptor
• Active Comparator: Medtronic Resolute Onyx Stent
  Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
  Intervention: Device: Resolute Onyx

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 18, 2020): 2400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2028
• Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)

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 requiring rotablation or atherectomy
• Bifurcation lesions requiring a planned 2 or more stent technique

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT04562805
• Other Study ID Numbers: ELX-CL-1806
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Elixir Medical Corporation
• Original Responsible Party: Same as current
• Current Study Sponsor: Elixir Medical Corporation
• Original Study Sponsor: Same as current
• Collaborators: Uppsala University

Investigators

• Principal Investigator: David Erlinge, MD, PhD; Skane University Hospital, Lund
• Study Chair: Stefan James, MD, PhD; Uppsala University

• PRS Account: Elixir Medical Corporation
• Verification Date: September 2023