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

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: Active, not recruiting
• Conditions: Coronary Artery Disease; Ischemic Heart Disease
• Intervention / Treatment: Device: DynamX Bioadaptor; Device: 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
• Enrollment (Estimated): 2400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Preciado, Ph.D.; Phone Number: +1-510-333-1437; Email: jpreciado@ElixirMedical.com
• Study Contact Backup: Name: Candace Elek, M.S.; Phone Number: +1-408-913-5468; Email: celek@elixirmedical.com

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
    • Sodersjukhuset
  • 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
    • Ostersunds sjukhus

Participation Criteria

Eligibility Criteria

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success	Lesion-Level Analysis	During Study Procedure
Procedural Success	Patient-Level Analysis	In-Hospital, assessed up to 7 days
Composite Rate of Device Oriented Clinical Endpoint (DOCE)	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)	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)	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	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)	Ischemia driven target lesion revascularization (ID-TLR)	30 days, 6 months, 1-5 years
Rate of Target Lesion Revascularization (TLR)	All Target Lesion Revascularization	30 days, 6 months, 1-5 years
Rate of Target Vessel Revascularization (TVR)	All Target Vessel Revascularization	30 days, 6 months, 1-5 years
Rate of Ischemia driven target vessel revascularization (ID-TVR)	Ischemia driven target vessel revascularization (ID-TVR)	30 days, 6 months, 1-5 years
Rate of Ischemia driven non target vessel revascularization (ID-NTVR)	Ischemia driven non target vessel revascularization (ID-NTVR)	30 days, 6 months, 1-5 years
Rate of Non target vessel revascularization (NTVR)	Non target vessel revascularization (NTVR)	30 days, 6 months, 1-5 years
Rate of All revascularization	All revascularization	30 days, 6 months, 1-5 years
Rate of Myocardial Infarction	All MI, Q-Wave and Non Q-Wave MI, TV-MI, NTV-MI	30 days, 6 months, 1-5 years
Rate of Death	Cardiovascular Death, All-Cause Death	30 days, 6 months, 1-5 years
Composite: Cardiovascular death or myocardial infarction	Composite: Cardiovascular death or myocardial infarction	30 days, 6 months, 1-5 years
Composite: All-cause death or myocardial infarction	Composite: All-cause death or myocardial infarction	30 days, 6 months, 1-5 years
Composite: All-cause death, myocardial infarction or target vessel revascularization	Composite: All-cause death, myocardial infarction or target vessel revascularization	30 days, 6 months, 1-5 years
Rate of any stroke	Any stroke (collected at 1 year and 5 years only)	1 year and 5 years
Anginal Status	Anginal Status by Seattle Angina Questionnaire-7 (SAQ-7)	30 days and 1 year
Rate of Stent Thrombosis	Composite: Probable or definite stent thrombosis Probable Stent Thrombosis Definite Stent Thrombosis	30 days, 6 months, 1-5 years

Collaborators and Investigators

• Sponsor: Elixir Medical Corporation
• Collaborators: Uppsala University
• Investigators: Principal Investigator: David Erlinge, MD, PhD, Skåne University Hospital, Lund; Study Chair: Stefan James, MD, PhD, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID 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