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Clinical Trials/NCT04562805
NCT04562805Active, not recruitingNot Applicable

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

Elixir Medical Corporation19 sites in 1 country2,400 target enrollmentStarted: September 30, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
2,400
Locations
19
Primary Endpoint
Target Lesion Failure (TLF)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
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.

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).
  • •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).
  • •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.
  • •If a planned Non-Target Lesion is present it must have been treated without complication* prior to randomization.
  • •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%.

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

Outcomes

Primary Outcomes

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))

Secondary Outcomes

  • Rate of Ischemia driven target vessel revascularization (ID-TVR)(30 days, 6 months, 1-5 years)
  • Composite Rate of Patient Oriented Clinical Endpoint (POCE)(30 days, 6 months, 1-5 years)
  • Rate of Target Vessel Failure (TVF)(30 days, 6 months, 1-5 years)
  • Composite Rate of cardiovascular death, any myocardial infarction and any revascularization(30 days, 6 months, 1-5 years)
  • Rate of Target Lesion Revascularization (TLR)(30 days, 6 months, 1-5 years)
  • Rate of Ischemia driven non target vessel revascularization (ID-NTVR)(30 days, 6 months, 1-5 years)
  • Rate of any stroke(1 year and 5 years)
  • Landmark Analysis(5 years or at the conclusion of the study)
  • Rate of Non target vessel revascularization (NTVR)(30 days, 6 months, 1-5 years)
  • Procedural Success(In-Hospital, assessed up to 7 days)
  • Rate of Ischemia driven target lesion revascularization (ID-TLR)(30 days, 6 months, 1-5 years)
  • Composite: Cardiovascular death or myocardial infarction(30 days, 6 months, 1-5 years)
  • Composite: All-cause death or myocardial infarction(30 days, 6 months, 1-5 years)
  • Device Success(During Study Procedure)
  • Composite Rate of Device Oriented Clinical Endpoint (DOCE)(30 days, 6 months, 1-5 years)
  • Rate of Myocardial Infarction(30 days, 6 months, 1-5 years)
  • Rate of Target Vessel Revascularization (TVR)(30 days, 6 months, 1-5 years)
  • Rate of All revascularization(30 days, 6 months, 1-5 years)
  • Rate of Death(30 days, 6 months, 1-5 years)
  • Composite: All-cause death, myocardial infarction or target vessel revascularization(30 days, 6 months, 1-5 years)
  • Anginal Status(30 days, 1,3,4 and 5 years)
  • Rate of Stent Thrombosis(30 days, 6 months, 1-5 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (19)

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