Clinical trial NCT04034121: Elixir Medical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - Cx Registry
Official title: Non-randomized Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System in de Novo Native Coronary Artery Lesions - DESolve Cx Single-Arm Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: biorersorbable scaffold
drug eluting
novolimus
Lead sponsor: Elixir Medical Corporation
Sponsor class: INDUSTRY
First posted: 2019-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm
Primary purpose: TREATMENT

Brief summary: This additional arm of the DESolve Nx study is an evaluation of the CE Mark approved DESolve Cx Novolimus Eluting Bioresorbable Scaffold System.

Detailed description: The DESolve Cx Single-Arm Registry enrolled patients using the same inclusion and exclusion criteria and clinical endpoints as the DESolve Nx Study

This study was split into 2 cohorts - European and Brazilian. The European cohort (30 subjects) completed all follow-up at 1 year and the Brazilian cohort at 3 years (20 subjects)

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 Novolimus Eluting Bioresorbable Coronary Scaffold System (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, imaging 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
* Not part of a clinical investigation
* Treatment of a single, non-target lesion located in a separate major epicardial vessel Target vessel diameter must be a diameter of between 2.25 and 3.5 mm assessed by online QCA
* 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
* Target vessel must be in a major coronary artery or major branch

Exclusion Criteria:

* Patient has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and cardiac enzymes 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
* Target lesion(s) meets any of the following criteria:
* Aorto-ostial location
* Left main location
* Located within 5 mm of the origin of the LAD or LCX
* Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
* Lesion involving a side branch \>2mm in diameter or bifurcation
* Previous placement of a scaffold proximal to or within 10 mm of the target lesion
* Total occlusion (TIMI flow 0), or TIMI flow \< 1
* Excessive tortuosity proximal to or within the lesion
* Angulation (≥ 45o) proximal to or within the lesion
* Calcification moderate or heavy
* 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
timeFrame: 6 months
Secondary outcomes:
measure: In-scaffold Late Lumen Loss by Quantitative Coronary Angiography (QCA)
timeFrame: 6 months
measure: Clinically-indicated Major Adverse Cardiac Events (MACE)
timeFrame: 12 months
measure: Clinically-Indicated Major Adverse Cardiac Events
timeFrame: 24 months
measure: Clinically-indicated Major Adverse Cardiac Events
timeFrame: 36 months
Other outcomes:
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
Study officials:
affiliation: ZNA Antwerp Belgium
name: Stefan Verheye, MD
role: PRINCIPAL_INVESTIGATOR
References: