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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System

• Registration Number: NCT02086045
• Lead Sponsor: Elixir Medical Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2013-06
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Study Completion: 2017-05-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 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

Angiographic Inclusion Criteria:

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:

  1. Not part of a clinical investigation
  2. ≥ 6 months prior to the study index procedure
  3. ≥ 9 months after the study index procedure (planned)
  4. Previous intervention was distal to and >10mm from the target lesion

Exclusion Criteria

• 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
• Patient has had a significant GI or urinary bleed within the past six months
• Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
• Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
• Patient is already participating in another clinical study
• Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal (defined as amenorrheic for at least one year) as well as women who are pregnant or nursing
• Patient is unable to give their consent, is legally incompetent, or is institutionalized by virtue of an order issued by the courts or other authority

Angiographic Exclusion Criteria

• Target lesion(s) meets any of the following criteria:

  1. Aorto-ostial location
  2. Left main location
  3. Located within 5 mm of the origin of the LAD or LCX
  4. Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
  5. Lesion involving a side branch >2mm in diameter or bifurcation
  6. Previous placement of a scaffold proximal to or within 10 mm of the target lesion
  7. Total occlusion (TIMI flow 0), or TIMI flow < 1
  8. Excessive tortuosity proximal to or within the lesion
  9. Angulation (≥ 45o) proximal to or within the lesion
  10. Calcification moderate or heavy
  11. Previous intervention restenosis

• The target vessel contains visible thrombus

• Another clinically significant lesion (>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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DESolve Novolimus Eluting Bioresorbable Coronary Scaffold	DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System	DESolve Scaffold

Primary Outcome Measures

Name	Time	Method
Clinically-indicated major adverse cardiac events (MACE)	6 months	cardiac death, target vessel MI, clinically indicated TLR
Late Lumen Loss	6 month	MLD post procedure - MLD at follow-up

Secondary Outcome Measures

Name	Time	Method
Clinically-Indicated Target Lesion Failure (TLF)	5 years	cardiac death, MI, clinically indicated TLR
Major Adverse Cardiac Events	5 months	cardiac death, target vessel MI, clinically indicated TLR
Scaffold Thrombosis	through 5 years	ARC defined
Clinically-Indicated Target Vessel Failure (TVF)	5 years	cardiac death, MI, clinically indicated TLR

Trial Locations

Locations (13)

Instituto Dante Pazzanese; 🇧🇷 Sao Paulo, Brazil

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus N, Denmark

AZ Middelheim Hospital; 🇧🇪 Antwerp, Belgium

Jagiellonian University; 🇵🇱 Krakow, Poland

Charite - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Universitäres Herz- und Gefäßzentrum; 🇩🇪 Hamburg, Germany

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Mercy Angiography Unit; 🇳🇿 Auckland, New Zealand

St. - Jan Ziekenhuis Z.O.L.; 🇧🇪 Genk, Belgium

ICT / Instituto Do Coracao Do Triangulo Mineiro; 🇧🇷 Uberlandia, Brazil

Centrum Interwencyjnego Leczenia Chorób Serca; 🇵🇱 Krakow, Poland

North Shore Hospital; 🇳🇿 Auckland, New Zealand

Polsko-Amerykańskie Kliniki Serca; 🇵🇱 Dąbrowa Górnicza, Poland