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Clinical Trials in Sweden / NCT04562805
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Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)

NCT04562805 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2020-09-30
Last updated
2024-10-16

Condition(s) studied

Coronary Artery DiseaseIschemic Heart Disease

Investigational drug(s) / intervention(s)

DynamX BioadaptorResolute Onyx

DynamX Bioadaptor: DynamX Bioadaptor Treatment

Resolute Onyx: Resolute Onyx Treatment

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Mälarsjukhuset Eskilstuna Eskilstuna Sweden
Hallands sjukhus Halmstad Sweden
Helsingborgs lasarett Helsingborg Sweden
Blekingesjukhuset i Karlskrona Karlskrona Sweden
Centralsjukhuset Karlstad Karlstad Sweden
Skånes Universitetssjukhus i Lund Lund Sweden
Skånes Universitetssjukhus i Malmö Malmö Sweden
Universitetssjukhuset Örebro Örebro Sweden
Östersunds sjukhus Östersund Sweden
Sunderby sjukhus Södra Sunderbyn Sweden
Capio St Görans sjukhus Stockholm Sweden
Danderyds sjukhus Stockholm Sweden
Karolinska Universitetssjukhuset Huddinge Stockholm Sweden
Karolinska Universitetssjukhuset Solna Stockholm Sweden
Södersjukhuset Stockholm Sweden
Sundsvall Hospital Sundsvall Sweden
Norrlands universitetssjukhus Umeå Umeå Sweden
Akademiska Sjukhuset Uppsala Sweden
Västmanlands sjukhus i Västerås Västerås Sweden

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04562805 on ClinicalTrials.gov ↗ ← All trials in Sweden