DESolve Post-Approval Study

NCT02013349 | Completed

• 1 other identifier: ELX-CL-1203
• Study Type: interventional
• Target: 102
• Locations: 3 countries
• Sites: 7

Brief Summary

To evaluate the long-term safety and performance of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (7)

• Major Adverse Cardiac Events (MACE)

  Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization

  1 month

• Major Adverse Cardiac Events (MACE)

  Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization

  6 months

• Major Adverse Cardiac Events (MACE)

  Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization

  12 months

• Major Adverse Cardiac Events (MACE)

  Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization

  2 years

• Major Adverse Cardiac Events (MACE)

  Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization

  3 years

• Major Adverse Cardiac Events (MACE)

  Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization

  4 years

• Major Adverse Cardiac Events (MACE)

  Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization

  5 years

Study Arms (1)

DESyne Novolimus Eluting CSS

OTHER

approved device continued access

Device: coronary intervention

Interventions

coronary intervention DEVICE

DESyne Novolimus Eluting CSS

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 verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DESolve NE 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
• Patient must agree not to participate in any other clinical study for a period of two years following the index procedure
• 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
• 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 \> 10 mm 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)
• 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 (7)

Herz-Kreislaufzentrum Bad Segeberg

Bad Segeberg, 23795, Germany

Location

Universitätsklinikum Giessen und Marburg GmbH

Giessen, 35392, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Krankenhaus der Barmherzigen Brüder

Trier, 54292, Germany

Location

Ospendale San Raffaele

Milan, 20132, Italy

Location

Jordan Hospital

Amman, 11152, Jordan

Location

King Abdullah University Hospital

Irbid, 22110, Jordan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

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

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: prospective, multi-center registry

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 17, 2013
• Study Start: April 22, 2014
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2019
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

DE (4); IT (1); JO (2)