Elixir Medical Clinical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - The DESolve Nx Trial

NCT02086045 | Completed DMC

• 1 other identifier: ELX-CL-1003
• Study Type: interventional
• Target: 126
• Locations: 6 countries
• Sites: 13

Brief Summary

To evaluate the safety, performance and efficacy of the Elixir DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System (BCSS) in patients with a single de novo native coronary artery lesion designated the target lesion and up to one non-target lesion located in a separate epicardial vessel.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease

Outcome Measures

Primary Outcomes (2)

• Clinically-indicated major adverse cardiac events (MACE)

  cardiac death, target vessel MI, clinically indicated TLR

  6 months

• Late Lumen Loss

  MLD post procedure - MLD at follow-up

  6 month

Secondary Outcomes (19)

• Major Adverse Cardiac Events

  1 month

• Major Adverse Cardiac Events

  12 months

• Major Adverse Cardiac Events

  24 months

• Major Adverse Cardiac Events

  3 years

• Major Adverse Cardiac Events

  4 years

Other Outcomes (2)

• Acute success - Procedure success

  7 days

• Acute success - Device success

  7 days

Study Arms (1)

DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

OTHER

DESolve Scaffold

Device: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System

Interventions

DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System DEVICE

percutaneous coronary

DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

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 Nx Novolimus Eluting 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, IVUS, OCT, MSCT and coronary vasomotion 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 diameter of between 2.75 and 3.5 mm assessed by online QCA
• Target lesion must measure ≤ 14 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
• Percutaneous intervention of lesions in the target vessel if:
• Not part of a clinical investigation
• ≥ 6 months prior to the study index procedure
• ≥ 9 months after the study index procedure (planned)
• Previous intervention was distal to and \>10mm from the target lesion

You may not qualify if:

• Patient has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and CK and CK-MB 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 (13)

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

ICT / Instituto Do Coracao Do Triangulo Mineiro

Uberlândia, 38400-368, Brazil

Location

Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Location

Charite - Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Universitäres Herz- und Gefäßzentrum

Hamburg, 22527, Germany

Location

North Shore Hospital

Auckland, 0622, New Zealand

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Mercy Angiography Unit

Auckland, 1023, New Zealand

Location

Polsko-Amerykańskie Kliniki Serca

Dąbrowa Górnicza, 43-300, Poland

Location

Centrum Interwencyjnego Leczenia Chorób Serca

Krakow, 31-202, Poland

Location

Jagiellonian University

Krakow, 31-501, Poland

Location

Related Publications (1)

• Abizaid A, Costa RA, Schofer J, Ormiston J, Maeng M, Witzenbichler B, Botelho RV, Costa JR Jr, Chamie D, Abizaid AS, Castro JP, Morrison L, Toyloy S, Bhat V, Yan J, Verheye S. Serial Multimodality Imaging and 2-Year Clinical Outcomes of the Novel DESolve Novolimus-Eluting Bioresorbable Coronary Scaffold System for the Treatment of Single De Novo Coronary Lesions. JACC Cardiovasc Interv. 2016 Mar 28;9(6):565-74. doi: 10.1016/j.jcin.2015.12.004.

  PMID: 27013155 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Alex Abizaid, MD, PhD

  Instituto Dante Pazzanese de Cardiologia

  PRINCIPAL INVESTIGATOR

• Stefan Verheye, MD, PhD

  AZ Middelheim Hospital

  PRINCIPAL INVESTIGATOR

• John Ormiston, MD

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

• Joachim Schofer, MD, PhD

  Universitäres Herz- und Gefäßzentrum

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 13, 2014
• Study Start: November 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: May 15, 2017
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

DK (1); PL (3); BE (2); BR (2); DE (2); NZ (3)