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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04562805
• Other study ID #: ELX-CL-1806
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: July 31, 2028

Study information

• Verified date: September 2023
• Source: Elixir Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2400
• Est. completion date: July 31, 2028
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Sweden	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

Sponsors (2)

Lead Sponsor	Collaborator
Elixir Medical Corporation	Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Landmark Analysis	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	5 years or at the conclusion of the study
Secondary	Device Success	Lesion-Level Analysis	During Study Procedure
Secondary	Procedural Success	Patient-Level Analysis	In-Hospital, assessed up to 7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of Ischemia driven target lesion revascularization (ID-TLR)	Ischemia driven target lesion revascularization (ID-TLR)	30 days, 6 months, 1-5 years
Secondary	Rate of Target Lesion Revascularization (TLR)	All Target Lesion Revascularization	30 days, 6 months, 1-5 years
Secondary	Rate of Target Vessel Revascularization (TVR)	All Target Vessel Revascularization	30 days, 6 months, 1-5 years
Secondary	Rate of Ischemia driven target vessel revascularization (ID-TVR)	Ischemia driven target vessel revascularization (ID-TVR)	30 days, 6 months, 1-5 years
Secondary	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
Secondary	Rate of Non target vessel revascularization (NTVR)	Non target vessel revascularization (NTVR)	30 days, 6 months, 1-5 years
Secondary	Rate of All revascularization	All revascularization	30 days, 6 months, 1-5 years
Secondary	Rate of Myocardial Infarction	All MI, Q-Wave and Non Q-Wave MI, TV-MI, NTV-MI	30 days, 6 months, 1-5 years
Secondary	Rate of Death	Cardiovascular Death, All-Cause Death	30 days, 6 months, 1-5 years
Secondary	Composite: Cardiovascular death or myocardial infarction	Composite: Cardiovascular death or myocardial infarction	30 days, 6 months, 1-5 years
Secondary	Composite: All-cause death or myocardial infarction	Composite: All-cause death or myocardial infarction	30 days, 6 months, 1-5 years
Secondary	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
Secondary	Rate of any stroke	Any stroke (collected at 1 year and 5 years only)	1 year and 5 years
Secondary	Anginal Status	Anginal Status by Seattle Angina Questionnaire-7 (SAQ-7)	30 days, 1,3,4 and 5 years
Secondary	Rate of Stent Thrombosis	Composite: Probable or definite stent thrombosis Probable Stent Thrombosis Definite Stent Thrombosis	30 days, 6 months, 1-5 years