Clinical trial NCT02086045: Elixir Medical Clinical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - The DESolve Nx Trial
Official title: A NON-RANDOMIZED, CONSECUTIVE ENROLLMENT EVALUATION OF THE DESolve® NOVOLIMUS ELUTING BIORESORBABLE CORONARY SCAFFOLD SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Lead sponsor: Elixir Medical Corporation
Sponsor class: INDUSTRY
First posted: 2014-03-13
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Clinically-indicated major adverse cardiac events (MACE)
timeFrame: 6 months
measure: Late Lumen Loss
timeFrame: 6 month
Secondary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: 1 month
measure: Major Adverse Cardiac Events
timeFrame: 12 months
measure: Major Adverse Cardiac Events
timeFrame: 24 months
measure: Major Adverse Cardiac Events
timeFrame: 3 years
measure: Major Adverse Cardiac Events
timeFrame: 4 years
measure: Major Adverse Cardiac Events
timeFrame: 5 months
measure: Clinically-Indicated Target Lesion Failure (TLF)
timeFrame: 1 month
measure: Clinically-Indicated Target Lesion Failure (TLF)
timeFrame: 6 months
measure: Clinically-Indicated Target Lesion Failure (TLF)
timeFrame: 1 year
measure: Clinically-Indicated Target Lesion Failure (TLF)
timeFrame: 2 years
measure: Clinically-Indicated Target Lesion Failure (TLF)
timeFrame: 3 years
measure: Clinically-Indicated Target Lesion Failure (TLF)
timeFrame: 4 years
measure: Clinically-Indicated Target Lesion Failure (TLF)
timeFrame: 5 years
measure: Clinically-Indicated Target Vessel Failure (TVF)
timeFrame: 1 year
measure: Clinically-Indicated Target Vessel Failure (TVF)
timeFrame: 2 years
measure: Clinically-Indicated Target Vessel Failure (TVF)
timeFrame: 3 years
measure: Clinically-Indicated Target Vessel Failure (TVF)
timeFrame: 4 years
measure: Clinically-Indicated Target Vessel Failure (TVF)
timeFrame: 5 years
measure: Scaffold Thrombosis
timeFrame: through 5 years
Other outcomes:
measure: Acute success - Procedure success
timeFrame: 7 days
measure: Acute success - Device success
timeFrame: 7 days
Locations:
city: Antwerp
country: Belgium
facility: AZ Middelheim Hospital
city: Genk
country: Belgium
facility: St. - Jan Ziekenhuis Z.O.L.
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese
city: Uberlandia
country: Brazil
facility: ICT / Instituto Do Coracao Do Triangulo Mineiro
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital, Skejby
city: Berlin
country: Germany
facility: Charite - Campus Benjamin Franklin
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Auckland
country: New Zealand
facility: Mercy Angiography Unit
city: Dąbrowa Górnicza
country: Poland
facility: Polsko-Amerykańskie Kliniki Serca
city: Krakow
country: Poland
facility: Centrum Interwencyjnego Leczenia Chorób Serca
city: Krakow
country: Poland
facility: Jagiellonian University
Study officials:
affiliation: Instituto Dante Pazzanese de Cardiologia
name: Alex Abizaid, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ Middelheim Hospital
name: Stefan Verheye, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Auckland City Hospital
name: John Ormiston, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitäres Herz- und Gefäßzentrum
name: Joachim Schofer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.