Coronary Artery DiseaseNCT02013349
DESolve Post-Approval Study
A study testing coronary intervention in people with Coronary Artery Disease, run by Elixir Medical Corporation at 7 sites in 3 countries.
Trial summary
To evaluate the long-term safety and performance of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- coronary intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 22 Apr 2014to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany4 sites
Herz-Kreislaufzentrum Bad Segeberg
Bad Segeberg, 23795
Universitätsklinikum Giessen und Marburg GmbH
Giessen, 35392
Universitätsklinikum Münster
Münster, 48149
Krankenhaus der Barmherzigen Brüder
Trier, 54292
Jordan2 sites
Jordan Hospital
Amman, 11152
King Abdullah University Hospital
Irbid, 22110
About this 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
To evaluate the long-term safety and performance of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System
Read the detailed description
DESolve is not currently approved for sale in the United States.
- Conditions
- Coronary Artery Disease
- Being tested
- coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary interventionDevice
| Study group | Role | What they receive |
|---|---|---|
| DESyne Novolimus Eluting CSS | Other | approved device continued access Receives: Device: coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
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
Measured: 6 months
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
Measured: 12 months
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
Measured: 2 years
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
Measured: 3 years
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
Measured: 4 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study start22 Apr 2014
- Primary completionOct 2015
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, multi-center registry
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elixir Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013349
- Sponsor's protocol ID
- ELX-CL-1203
- Status last verified
- Apr 2020
- First submitted
- 6 Dec 2013
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02013349
- Acronym / sponsor ID
- ELX-CL-1203
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Elixir Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2014 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, multi-center registry
| Arm | Type | Receives |
|---|---|---|
| DESyne Novolimus Eluting CSS | Other | Device: coronary interventionapproved device continued access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (34 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary intervention | Device | DESyne Novolimus Eluting CSS |
Primary outcome
Major Adverse Cardiac Events (MACE)
Time frame: 1 month
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)
Time frame: 6 months
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)
Time frame: 12 months
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)
Time frame: 2 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
Major Adverse Cardiac Events (MACE)
Time frame: 3 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
Major Adverse Cardiac Events (MACE)
Time frame: 4 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
Major Adverse Cardiac Events (MACE)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coronary intervention in people with Coronary Artery Disease, run by Elixir Medical Corporation at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Jordan, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (MACE) (time frame: 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.