Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02086045




Registration number
NCT02086045
Ethics application status
Date submitted
10/03/2014
Date registered
13/03/2014
Date last updated
7/09/2023

Titles & IDs
Public title
Elixir Medical Clinical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - The DESolve Nx Trial
Scientific title
A NON-RANDOMIZED, CONSECUTIVE ENROLLMENT EVALUATION OF THE DESolve® NOVOLIMUS ELUTING BIORESORBABLE CORONARY SCAFFOLD SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS
Secondary ID [1] 0 0
ELX-CL-1003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System

Other: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold - DESolve Scaffold


Treatment: Devices: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System
percutaneous coronary
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinically-indicated major adverse cardiac events (MACE)
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Late Lumen Loss
Timepoint [2] 0 0
6 month
Secondary outcome [1] 0 0
Major Adverse Cardiac Events
Timepoint [1] 0 0
1 month
Secondary outcome [2] 0 0
Major Adverse Cardiac Events
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Major Adverse Cardiac Events
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Major Adverse Cardiac Events
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
Major Adverse Cardiac Events
Timepoint [5] 0 0
4 years
Secondary outcome [6] 0 0
Major Adverse Cardiac Events
Timepoint [6] 0 0
5 months
Secondary outcome [7] 0 0
Clinically-Indicated Target Lesion Failure (TLF)
Timepoint [7] 0 0
1 month
Secondary outcome [8] 0 0
Clinically-Indicated Target Lesion Failure (TLF)
Timepoint [8] 0 0
6 months
Secondary outcome [9] 0 0
Clinically-Indicated Target Lesion Failure (TLF)
Timepoint [9] 0 0
1 year
Secondary outcome [10] 0 0
Clinically-Indicated Target Lesion Failure (TLF)
Timepoint [10] 0 0
2 years
Secondary outcome [11] 0 0
Clinically-Indicated Target Lesion Failure (TLF)
Timepoint [11] 0 0
3 years
Secondary outcome [12] 0 0
Clinically-Indicated Target Lesion Failure (TLF)
Timepoint [12] 0 0
4 years
Secondary outcome [13] 0 0
Clinically-Indicated Target Lesion Failure (TLF)
Timepoint [13] 0 0
5 years
Secondary outcome [14] 0 0
Clinically-Indicated Target Vessel Failure (TVF)
Timepoint [14] 0 0
1 year
Secondary outcome [15] 0 0
Clinically-Indicated Target Vessel Failure (TVF)
Timepoint [15] 0 0
2 years
Secondary outcome [16] 0 0
Clinically-Indicated Target Vessel Failure (TVF)
Timepoint [16] 0 0
3 years
Secondary outcome [17] 0 0
Clinically-Indicated Target Vessel Failure (TVF)
Timepoint [17] 0 0
4 years
Secondary outcome [18] 0 0
Clinically-Indicated Target Vessel Failure (TVF)
Timepoint [18] 0 0
5 years
Secondary outcome [19] 0 0
Scaffold Thrombosis
Timepoint [19] 0 0
through 5 years

Eligibility
Key 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 Nx Novolimus Eluting 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, IVUS, OCT, MSCT and coronary vasomotion testing

- Patient must agree not to participate in any other clinical study for a period of two
years following the index procedure

Angiographic

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 online QCA

- Target lesion must measure = 14 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:

1. Not part of a clinical investigation

2. = 6 months prior to the study index procedure

3. = 9 months after the study index procedure (planned)

4. Previous intervention was distal to and >10mm from the target lesion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
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

Angiographic Exclusion Criteria

- Target lesion(s) meets any of the following criteria:

1. Aorto-ostial location

2. Left main location

3. Located within 5 mm of the origin of the LAD or LCX

4. Located within an arterial or saphenous vein graft or distal to a diseased
arterial or saphenous vein graft

5. Lesion involving a side branch >2mm in diameter or bifurcation

6. Previous placement of a scaffold proximal to or within 10 mm of the target lesion

7. Total occlusion (TIMI flow 0), or TIMI flow < 1

8. Excessive tortuosity proximal to or within the lesion

9. Angulation (= 45o) proximal to or within the lesion

10. Calcification moderate or heavy

11. 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2017
Sample size
Target
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Genk
Country [3] 0 0
Brazil
State/province [3] 0 0
Sao Paulo
Country [4] 0 0
Brazil
State/province [4] 0 0
Uberlandia
Country [5] 0 0
Denmark
State/province [5] 0 0
Aarhus N
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Germany
State/province [7] 0 0
Hamburg
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
Poland
State/province [9] 0 0
Dabrowa Górnicza
Country [10] 0 0
Poland
State/province [10] 0 0
Krakow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Elixir Medical Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the safety, performance and efficacy of the Elixir DESolve® Novolimus Eluting
Bioresorbable Coronary Scaffold System (BCSS) in patients with a single de novo native
coronary artery lesion designated the target lesion and up to one non-target lesion located
in a separate epicardial vessel.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02086045
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alex Abizaid, MD, PhD
Address 0 0
Instituto Dante Pazzanese de Cardiologia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02086045