DESolve Post-Approval Study

Elixir Medical

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: coronary intervention

Study type

Interventional

Funder types

Industry

Identifiers

NCT02013349

ELX-CL-1203

Details and patient eligibility

About

To evaluate the long-term safety and performance of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System

Full description

DESolve is not currently approved for sale in the United States.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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