Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT04562805
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04562805
Study Brief:
Protocol Section:
NCT04562805