DESolve Post-Approval Study
Not Applicable
Completed
- Conditions
- Coronary Artery Disease
- Interventions
- Device: coronary intervention
- Registration Number
- NCT02013349
- Lead Sponsor
- Elixir Medical Corporation
- Brief Summary
To evaluate the long-term safety and performance of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System
- Detailed Description
DESolve is not currently approved for sale in the United States.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
Inclusion Criteria
- 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
Angiographic Inclusion Criteria - Target Lesion/Vessel 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 visual estimation or 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
- 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
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)
- 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/Vessel
- 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 sub-total occlusion (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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DESyne Novolimus Eluting CSS coronary intervention approved device continued access
- Primary Outcome Measures
Name Time Method Major Adverse Cardiac Events (MACE) 5 years 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Jordan Hospital
🇯🇴Amman, Jordan
King Abdullah University Hospital
🇯🇴Irbid, Jordan
Universitätsklinikum Giessen und Marburg GmbH
🇩🇪Giessen, Germany
Herz-Kreislaufzentrum Bad Segeberg
🇩🇪Bad Segeberg, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Krankenhaus der Barmherzigen Brüder
🇩🇪Trier, Germany
Ospendale San Raffaele
🇮🇹Milan, Italy