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

Not Applicable

Active, not recruiting

• Conditions: Ischemic Heart Disease; Coronary Artery Disease
• Interventions: Device: DynamX Bioadaptor; Device: Resolute Onyx

• Registration Number: NCT04562805
• Lead Sponsor: Elixir Medical Corporation

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 Timeline

• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-18
• Study First Posted: 2020-09-24
• Study Start: 2020-09-30
• Primary Completion: 2024-09-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DynamX Bioadaptor	DynamX Bioadaptor	Elixir Medical DynamX™ Sirolimus Eluting Coronary Bioadaptor
Medtronic Resolute Onyx Stent	Resolute Onyx	Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	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

Name	Time	Method
Composite: All-cause death, myocardial infarction or target vessel revascularization	30 days, 6 months, 1-5 years	Composite: All-cause death, myocardial infarction or target vessel revascularization
Anginal Status	30 days, 1,3,4 and 5 years	Anginal Status by Seattle Angina Questionnaire-7 (SAQ-7)
Rate of Stent Thrombosis	30 days, 6 months, 1-5 years	Composite: Probable or definite stent thrombosis Probable Stent Thrombosis Definite Stent Thrombosis
Procedural Success	In-Hospital, assessed up to 7 days	Patient-Level Analysis
Rate of Ischemia driven target lesion revascularization (ID-TLR)	30 days, 6 months, 1-5 years	Ischemia driven target lesion revascularization (ID-TLR)
Composite: Cardiovascular death or myocardial infarction	30 days, 6 months, 1-5 years	Composite: Cardiovascular death or myocardial infarction
Composite: All-cause death or myocardial infarction	30 days, 6 months, 1-5 years	Composite: All-cause death or myocardial infarction
Device Success	During Study Procedure	Lesion-Level Analysis
Composite Rate of Device Oriented Clinical Endpoint (DOCE)	30 days, 6 months, 1-5 years	Composite Device Oriented Clinical Endpoint (DOCE) (TLF; cardiovascular death, TV-MI, ischemia-driven TLR)
Landmark Analysis	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
Rate of Ischemia driven target vessel revascularization (ID-TVR)	30 days, 6 months, 1-5 years	Ischemia driven target vessel revascularization (ID-TVR)
Composite Rate of Patient Oriented Clinical Endpoint (POCE)	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)	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	30 days, 6 months, 1-5 years	Composite of cardiovascular death, any myocardial infarction and any revascularization
Rate of Target Lesion Revascularization (TLR)	30 days, 6 months, 1-5 years	All Target Lesion Revascularization
Rate of Ischemia driven non target vessel revascularization (ID-NTVR)	30 days, 6 months, 1-5 years	Ischemia driven non target vessel revascularization (ID-NTVR)
Rate of any stroke	1 year and 5 years	Any stroke (collected at 1 year and 5 years only)
Rate of Non target vessel revascularization (NTVR)	30 days, 6 months, 1-5 years	Non target vessel revascularization (NTVR)
Rate of Myocardial Infarction	30 days, 6 months, 1-5 years	All MI, Q-Wave and Non Q-Wave MI, TV-MI, NTV-MI
Rate of Target Vessel Revascularization (TVR)	30 days, 6 months, 1-5 years	All Target Vessel Revascularization
Rate of All revascularization	30 days, 6 months, 1-5 years	All revascularization
Rate of Death	30 days, 6 months, 1-5 years	Cardiovascular Death, All-Cause Death

Trial Locations

Locations (19)

Centralsjukhuset Karlstad; 🇸🇪 Karlstad, Sweden

Skånes Universitetssjukhus i Lund; 🇸🇪 Lund, Sweden

Akademiska Sjukhuset; 🇸🇪 Uppsala, Sweden

Hallands sjukhus; 🇸🇪 Halmstad, Sweden

Mälarsjukhuset Eskilstuna; 🇸🇪 Eskilstuna, Sweden

Helsingborgs lasarett; 🇸🇪 Helsingborg, Sweden

Blekingesjukhuset i Karlskrona; 🇸🇪 Karlskrona, Sweden

Skånes Universitetssjukhus i Malmö; 🇸🇪 Malmö, Sweden

Capio St Görans sjukhus; 🇸🇪 Stockholm, Sweden

Karolinska Universitetssjukhuset Solna; 🇸🇪 Stockholm, Sweden

Danderyds sjukhus; 🇸🇪 Stockholm, Sweden

Karolinska Universitetssjukhuset Huddinge; 🇸🇪 Stockholm, Sweden

Sundsvall Hospital; 🇸🇪 Sundsvall, Sweden

Södersjukhuset; 🇸🇪 Stockholm, Sweden

Norrlands universitetssjukhus Umeå; 🇸🇪 Umeå, Sweden

Sunderby sjukhus; 🇸🇪 Södra Sunderbyn, Sweden

Västmanlands sjukhus i Västerås; 🇸🇪 Västerås, Sweden

Östersunds sjukhus; 🇸🇪 Östersund, Sweden

Universitetssjukhuset Örebro; 🇸🇪 Örebro, Sweden