The DESyne BDS Plus RCT: A Randomized Clinical Trial to Assess the Elixir DESyne BDS Plus Drug Eluting Coronary Stent System for the Treatment of de Novo Native Coronary Artery Lesions

NCT05033964 | Active Not Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: ELX-CL-2005
• Study Type: interventional
• Target: 200
• Locations: 5 countries
• Sites: 14

Brief Summary

The objective of this clinical trial is to confirm the safety, effectiveness and performance of the DESyne BDS Plus Drug Eluting Coronary Stent System (DESyne BDS Plus DECSS) (Test) as compared to the CE Mark approved DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) (Control) in the treatment of de novo native coronary artery lesions.

Conditions

Coronary Artery Disease

Keywords

Drug Eluting Coronary Stent

Outcome Measures

Primary Outcomes (1)

• Target lesion failure

  defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization

  3 days or through hospital discharge, whichever comes first

Secondary Outcomes (33)

• Acute success

  during hospital stay with a maximum of first seven days post index procedure

• Target lesion failure

  30 days

• Target lesion failure

  6 months

• Target lesion failure

  12 months

• Target lesion failure

  2 years

Study Arms (2)

DESyne BDS Plus Arm

EXPERIMENTAL

DESyne BDS Plus Drug Eluting Coronary Stent System (DESyne BDS Plus DECSS; DESyne BDS Plus) is loaded with Sirolimus, Rivaroxaban and Argatroban

Combination Product: Percutaneous Coronary Intervention with drug eluting stents

DESyne X2 Arm

ACTIVE COMPARATOR

The DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) is loaded with Novolimus

Combination Product: Percutaneous Coronary Intervention with drug eluting stents

Interventions

Percutaneous Coronary Intervention with drug eluting stents COMBINATION_PRODUCT

Coronary drug eluting stent implantation

DESyne BDS Plus Arm; DESyne X2 Arm

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
• Patient is able to understand the risks, benefits and treatment alternatives of receiving the DESyne BDS Plus DECSS or the DESyne X2 NECSS and provide written informed consent or oral consent (in urgent PCI) as allowed per hospital standard and as approved by the local Ethics Committee, prior to any clinical study-related procedure
• Indication for a percutaneous intervention with stent implantation in native epicardial arteries including patients with stable coronary artery disease and acute coronary syndromes including NSTEMI and STEMI.
• Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
• Patient agrees to undergo all clinical study required follow up visits, angiograms, and imaging testing (as applicable)
• Patient agrees not to participate in any other clinical research study for a period of one year following the index procedure (long term follow-up or observational studies are permitted)
• Target lesion(s) must be de novo coronary artery lesion(s) and must be located in a separate\* vessel from other target or non-target lesions.
• Target lesion(s) must have a reference vessel diameter (RVD) of ≥ 2.25 and ≤ 3.5 mm by visual estimation
• Target lesion(s) must measure ≤ 34 mm in length, and able to be covered by a single device with 2 mm of healthy vessel on either side of planned implantation site
• Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \<100%. When two target lesions are treated, they must be located in separate major epicardial vessels

You may not qualify if:

• Acute myocardial infarction with Killip Class III and IV
• Acute myocardial infarction requiring resuscitation
• Acute myocardial infarction requiring IABP or ventilation support
• Patient had fibrinolysis prior to PCI
• Patient has current unstable ventricular 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 an 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, other than steroids or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
• Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, prasugrel or ticagrelor, Novolimus, Sirolimus, Rivaroxaban, Argatroban, CoCr alloys, 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 or other P2Y12 inhibitors
• Patient has severe renal dysfunction (CKD IV or V, eGFR \<30) or is on dialysis
• Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
• Patient has had a significant GI or urinary bleed within the past six months
• Women of childbearing potential (unless they have a negative pregnancy test within 7 days of index procedure), or women who are pregnant or nursing

Sponsors & Collaborators

• Elixir Medical Corporation: lead

Study Sites (14)

ZNA Middelheim

Antwerp, 2020, Belgium

Location

AZ Sint Jan Brugge Oostende AV

Bruges, 8000, Belgium

Location

Ziekenhuis Oost-Limburg, Campus Sint Jan

Genk, 3600, Belgium

Location

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

Instituto Dante Pazzanese

São Paulo, 04012-909, Brazil

Location

Instituto do Coração da Faculdade

São Paulo, 05403, Brazil

Location

General University Hospital

Prague, 12808, Czechia

Location

Catharina Hospital

Eindhoven, 5623 EJ, Netherlands

Location

North Shore Hospital

Auckland, 0622, New Zealand

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Middlemore Hospital

Auckland, 2025, New Zealand

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

Dunedin Hospital

Dunedin, 9016, New Zealand

Location

Waikato Hospital

Hamilton, 3240, New Zealand

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention; Drug-Eluting Stents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Stefan Verheye, MD, PHD

  Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim, Antwerp, Belgium

  PRINCIPAL INVESTIGATOR

• Mark Webster, MBChB

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, multi-center, single blind, randomized clinical study. Randomization is 1:1

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: September 5, 2021
• Study Start: December 15, 2021
• Primary Completion: December 2, 2022
• Study Completion: March 1, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); NZ (6); BE (4); BR (2); CZ (1)