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

NCT04034121 | Completed Results FDA Device

• 1 other identifier: ELX-CL-1003 Cx
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

biorersorbable scaffold; drug eluting; novolimus

Outcome Measures

Primary Outcomes (1)

• Clinically-indicated Major Adverse Cardiac Events

  Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to the European and Brazilian Cohorts

  6 months

Secondary Outcomes (4)

• In-scaffold Late Lumen Loss by Quantitative Coronary Angiography (QCA)

  6 months

• Clinically-indicated Major Adverse Cardiac Events (MACE)

  12 months

• Clinically-Indicated Major Adverse Cardiac Events

  24 months

• Clinically-indicated Major Adverse Cardiac Events

  36 months

Study Arms (1)

DESolve Cx

OTHER

DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System

Device: DESolve Cx drug eluting coronary scaffold system

Interventions

DESolve Cx drug eluting coronary scaffold system DEVICE

percutaneous coronary intervention

DESolve Cx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 90% with a TIMI flow of ≥ 1
• Target vessel must be in a major coronary artery or major branch

You may not qualify if:

• Patient has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and cardiac enzymes have not returned within normal limits at the time of procedure
• Patient is currently experiencing clinical symptoms consistent with AMI
• Patient requires the use of any rotablator intervention during the index procedure
• Patient has current unstable arrhythmias
• Patient has a known left ventricular ejection fraction (LVEF) \< 30%
• Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
• Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
• Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
• Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) that cannot be stopped and restarted according to local hospital standard procedures.
• Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, Novolimus, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated
• Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
• Patient has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3, or documented or suspected liver disease.
• Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
• Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months

Sponsors & Collaborators

• Elixir Medical Corporation: lead

Study Sites (3)

AZ Middelheim Hospital

Antwerp, 2020, Belgium

Location

St. - Jan Ziekenhuis Z.O.L.

Genk, B-3600, Belgium

Location

Instituto Dante Pazzanese

São Paulo, 0401210, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Candace Elek, Executive Vice President, Clinical Research
• Organization: Elixir Medical

celek@elixirmedical.com

408-636-2020

Study Officials

• Stefan Verheye, MD

  ZNA Antwerp Belgium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single arm

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: July 26, 2019
• Study Start: January 20, 2016
• Primary Completion: January 22, 2017
• Study Completion: September 30, 2020
• Last Updated: July 14, 2021
• Results First Posted: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); BE (2)