Coronary Artery Disease
Conditions
Keywords
biorersorbable scaffold, drug eluting, novolimus
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)
Interventions
DEVICEDESolve Cx drug eluting coronary scaffold system
percutaneous coronary intervention
Sponsors
Elixir Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically-indicated Major Adverse Cardiac Events | 6 months | Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to the European and Brazilian Cohorts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-scaffold Late Lumen Loss by Quantitative Coronary Angiography (QCA) | 6 months | quantitative QCA measurement of change in the lumen diameter from post procedure and 6 months which is described as late lumen loss This applies to both the European and Brazilian Cohorts |
| Clinically-indicated Major Adverse Cardiac Events (MACE) | 12 months | Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to both the European and Brazilian Cohorts |
| Clinically-Indicated Major Adverse Cardiac Events | 24 months | Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This time point applies to the Brazilian Cohort only |
| Clinically-indicated Major Adverse Cardiac Events | 36 months | Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to the Brazilian Cohort only |
Countries
Belgium, Brazil
Participant flow
Recruitment details
Between 20 January 2016 and 18 July 2016 Nov 2017, 50 patients were enrolled in the study at 3 centers in Brazil (20 patients) and Belgium (30 patients)
Participants by arm
| Arm | Count |
|---|---|
| DESolve Cx DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System
The DESolve Cx Novolimus Eluting BCSS is comprised of four main components: the Poly-L-Lactic Acid-based polymer (PLLA) stent coated with a PLLA-based polymer-drug matrix containing the anti-proliferative drug Novolimus. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | DESolve Cx | — |
|---|---|---|
| Age, Continuous Age | 60.0 years STANDARD_DEVIATION 10.3 | — |
| Baseline Lesion Characteristics Lesion Length | 16.16 mm STANDARD_DEVIATION 6.55 | — |
| Baseline Lesion Characteristics Minimum Lumen Diameter | 1.17 mm STANDARD_DEVIATION 0.3 | — |
| Baseline Lesion Characteristics Reference Vessel Diameter | 3.03 mm STANDARD_DEVIATION 0.39 | — |
| Cardiac Risk Factors Diabetes | 10 Participants | — |
| Cardiac Risk Factors Dyslipidemia | 42 Participants | — |
| Cardiac Risk Factors Family history of coronary artery disease | 24 Participants | — |
| Cardiac Risk Factors Hypertension | 35 Participants | — |
| Cardiac Risk Factors Prior myocardial infarction | 20 Participants | — |
| Cardiac Risk Factors Prior percutaneous coronary intervention | 13 Participants | — |
| Cardiac Risk Factors Smoking (previous or current) | 35 Participants | — |
| Percent Diameter Stenosis | 61.20 Percent STANDARD_DEVIATION 9.27 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 30 participants | — |
| Region of Enrollment Brazil | 20 participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 34 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 2 / 50 |
Outcome results
Primary
Clinically-indicated Major Adverse Cardiac Events
Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to the European and Brazilian Cohorts
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DESolve Cx | Clinically-indicated Major Adverse Cardiac Events | 0 Participants |
Secondary
Clinically-indicated Major Adverse Cardiac Events
Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to the Brazilian Cohort only
Time frame: 36 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DESolve Cx | Clinically-indicated Major Adverse Cardiac Events | 0 Participants |
Secondary
Clinically-Indicated Major Adverse Cardiac Events
Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This time point applies to the Brazilian Cohort only
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DESolve Cx | Clinically-Indicated Major Adverse Cardiac Events | 0 Participants |
Secondary
Clinically-indicated Major Adverse Cardiac Events (MACE)
Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to both the European and Brazilian Cohorts
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DESolve Cx | Clinically-indicated Major Adverse Cardiac Events (MACE) | 0 Participants |
Secondary
In-scaffold Late Lumen Loss by Quantitative Coronary Angiography (QCA)
quantitative QCA measurement of change in the lumen diameter from post procedure and 6 months which is described as late lumen loss This applies to both the European and Brazilian Cohorts
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DESolve Cx | In-scaffold Late Lumen Loss by Quantitative Coronary Angiography (QCA) | 0.19 mm | Standard Deviation 0.25 |