N/A Completed N=30 Treatment

Elixir Medical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - Cx Registry

Coronary Artery Disease

Source: ClinicalTrials.gov NCT04034121 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Jul 2021

Primary outcomePrimary: Clinically-indicated Major Adverse Cardiac Events — 0 Participants

Summary

This additional arm of the DESolve Nx study is an evaluation of the CE Mark approved DESolve Cx Novolimus Eluting Bioresorbable Scaffold System.

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinically-indicated Major Adverse Cardiac Events	—	—
SECONDARY In-scaffold Late Lumen Loss by Quantitative Coronary Angiography (QCA)	0.19	—
SECONDARY Clinically-indicated Major Adverse Cardiac Events (MACE)	—	—
SECONDARY Clinically-Indicated Major Adverse Cardiac Events	—	—

Eligibility Criteria

Inclusion Criteria

Patient must be at least 18 years of age and for the 35-patient subset, patients must be over the age of 50
Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System (BCSS) and he/she provides written informed consent, as approved by the appropriate Ethics Committee of the respective clinical site, prior to any clinical study related procedure
Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or electrocardiogram (ECG) changes consistent with ischemia)
Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
Patient must agree to undergo all clinical study required follow-up visits, angiograms, and as applicable, imaging testing
Patient must agree not to participate in any other clinical study for a period of two years following the index procedure
Target lesion must be located in a native coronary artery with a nominal vessel
Not part of a clinical investigation
Treatment of a single, non-target lesion located in a separate major epicardial vessel Target vessel diameter must be a diameter of between 2.25 and 3.5 mm assessed by online QCA
Target lesion must measure ≤ 24 mm in length
Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and 700,000 cells/mm3, a WBC of 2mm in diameter or bifurcation
Previous placement of a scaffold proximal to or within 10 mm of the target lesion
Total occlusion (TIMI flow 0), or TIMI flow 40%) is located in the same major epicardial vessel as the target lesion
Patient has a high probability that a procedure other than pre-dilatation and scaffolding and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04034121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.