DESolve Post-Approval Study
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
coronary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- Herz-Kreislaufzentrum Bad Segeberg
- Universitätsklinikum Giessen und Marburg GmbH
- Universitätsklinikum Münster
- Krankenhaus der Barmherzigen Brüder
- Ospendale San Raffaele
- Jordan Hospital
- King Abdullah University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
DESyne Novolimus Eluting CSS
Arm Description
approved device continued access
Outcomes
Primary Outcome Measures
Major Adverse Cardiac Events (MACE)
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
Major Adverse Cardiac Events (MACE)
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
Major Adverse Cardiac Events (MACE)
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
Major Adverse Cardiac Events (MACE)
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
Major Adverse Cardiac Events (MACE)
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
Major Adverse Cardiac Events (MACE)
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
Major Adverse Cardiac Events (MACE)
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
Full Information
NCT ID
NCT02013349
First Posted
December 6, 2013
Last Updated
April 6, 2020
Sponsor
Elixir Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02013349
Brief Title
DESolve Post-Approval Study
Official Title
POST-MARKET EVALUATION OF DESolve® NOVOLIMUS ELUTING BIORESORBABLE CORONARY SCAFFOLD SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 22, 2014 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elixir Medical Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective, multi-center registry
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DESyne Novolimus Eluting CSS
Arm Type
Other
Arm Description
approved device continued access
Intervention Type
Device
Intervention Name(s)
coronary intervention
Primary Outcome Measure Information:
Title
Major Adverse Cardiac Events (MACE)
Description
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
Time Frame
1 month
Title
Major Adverse Cardiac Events (MACE)
Description
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
Time Frame
6 months
Title
Major Adverse Cardiac Events (MACE)
Description
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
Time Frame
12 months
Title
Major Adverse Cardiac Events (MACE)
Description
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
Time Frame
2 years
Title
Major Adverse Cardiac Events (MACE)
Description
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
Time Frame
3 years
Title
Major Adverse Cardiac Events (MACE)
Description
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
Time Frame
4 years
Title
Major Adverse Cardiac Events (MACE)
Description
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
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Herz-Kreislaufzentrum Bad Segeberg
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Universitätsklinikum Giessen und Marburg GmbH
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Ospendale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Jordan Hospital
City
Amman
ZIP/Postal Code
11152
Country
Jordan
Facility Name
King Abdullah University Hospital
City
Irbid
ZIP/Postal Code
22110
Country
Jordan
12. IPD Sharing Statement
Learn more about this trial
DESolve Post-Approval Study
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