Non-randomized Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System in de Novo Native Coronary Artery Lesions - DESolve Cx Single-Arm Registry
Phase: NA
Conditions: Coronary Artery Disease
Sponsor: Elixir Medical Corporation

Elixir Medical   
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Protocol Summary ELX-CL-1003, Rev E_Brazil 
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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 
 
Elixir Medical Clinical Evaluation of the DESolve® Novolimus Eluting Bioresorbable 
Coronary Scaffold System 
 
“DESolve Nx Trial – DESolve CX Arm” 
 
Revision E, 5 February 2018 
Brazil 
 
NCT04034121 
 
 
 

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Protocol Summary ELX-CL-1003, Rev E_Brazil 
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CLINICAL STUDY SUMMARY 
Trial Name and 
Number 
DESolve Nx Trial:  ELX-CL-1003 
 
Objectives: 
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.  
Enrollment: 
The study is designed to enroll 120 non-randomized 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. The target 
lesion must measure between 2.75 mm and 3.5 mm in diameter and ≤ 10 
mm or ≤ 14 mm in length able to be covered by a single 3.0 x 14, 3.0 x 
18mm, 3.25 x 14 or 3.25 x 18 mm, 3.5 x 14 mm or 3.5 x 18 mm DESolve 
scaffold.  As applicable, a non-target lesion located in a separate 
epicardial vessel must be treated first with a single, approved ‘olimus drug 
eluting stent and if this procedure is uncomplicated and considered 
optimal, then the target lesion can be considered for the DESolve 
Novolimus Eluting BCSS. The patient should not be enrolled until after 
satisfactory pre-dilatation of the target lesion. Enrollment and follow-up is 
complete. 
 
The Low Profile 1 study arm is designed to enroll 100 non-randomized 
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. The target lesion must measure between 2.75 mm and 
3.5 mm in diameter and ≤ 10 mm or ≤ 24 mm in length able to be covered 
by a single 3.0, 3.25 or 3.5 mm x 14, 18 or 28 mm scaffold.  This device 
differs only in the thickness of the scaffold which is now 100-120 µm as 
compared to the 150 µm of the device previously studied and shown safe 
and effective. As applicable, a non-target lesion located in a separate 
epicardial vessel must be treated first with a single, approved ‘olimus drug 
eluting stent and if this procedure is uncomplicated and considered 
optimal, then the target lesion can be considered for the DESolve 
Novolimus Eluting BCSS. The patient should not be enrolled until after 
satisfactory pre-dilatation of the target lesion.  Patients included in this 

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Protocol Summary ELX-CL-1003, Rev E_Brazil 
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Arm will be enrolled at select sites.  Follow-up will conclude at the end of 
3 years. 
Clinical Study Device 3.0 x 14 mm, 3.0 x 18 mm, and 3.0 x 28mm;  3.25 x 14 mm, 3.25 x 18 
mm and 3.25 x 28 mm;  3.5 x 14mm, 3.5 x 18 mm and 3.5 x 28 mm 
DESolve scaffolds  
All DESolve scaffolds are loaded with approximately 5 mcg of 
Novolimus per mm of scaffold length (i.e, 65 mcg on a 14 mm scaffold, 
85 mcg on an 18 mm scaffold and 125 mcg on a 28 mm scaffold).   
Clinical Site 
Locations: 
Drawn from up to 15 International Sites in Brazil, Belgium, Denmark, 
Germany, Poland and  New Zealand  
Clinical Study Design The DESolve Nx Trial is a prospective, consecutive enrolment non-
randomized study designed to enroll patients with a de novo lesion ≤ 14 
mm in length, designated the target lesion, located in a native coronary 
artery with a reference vessel diameter of 2.75 mm – 3.5 mm.  All patients 
will receive a 3.0, 3.25 or 3.5 mm x 14, 18 or 28 mm scaffold.  DESolve 
scaffold loaded with approximately 5 mcg of Novolimus per mm of 
scaffold length.  As appropriate, a non-target lesion may be treated in a 
separate native epicardial vessel with a single, approved ‘olimus drug 
eluting stent.  Only the target vessel will be evaluated for the key safety 
and efficacy endpoints. 
Multiple registry arms are to be included in the study with patients to be 
enrolled at select sites: 
• Low Profile 1 – a lower profile (thinner) scaffold (100-120µm) 
with the same drug dose  
 
To provide an assessment of the lesion and scaffold morphology and 
scaffold strut composition over time, the following additional imaging 
modalities will be included: 
• Angiography will be completed at 6 months following the index 
procedure in all patients.  
• In a subset of the first 35 patients enrolled at select sites, IVUS 
and OCT will be conducted at 6 and 24 and/or 36 months 
following the index procedure.  These patients will also undergo 
angiography during the 24 and/or 36 month follow-up.  

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• Multislice computed tomography (MSCT) will be conducted at 12 
months in the subset of the first 35 patients enrolled at select sites.   
• All main trial patients will undergo clinical follow-up at 1, 6, and 
12 months and annually through 5 years. 
• LP1 patients will undergo clinical follow-up at 1, 6, and 12 
months and annually through 3 years 
Clinical Endpoints:   
 
• Clinically-indicated Major Adverse Cardiac Events (MACE) at 1, 
6, and 12 months and annually to 5 years for all main study 
patients and for Low Profile 1 (LP1) patients at 1, 6, and 12 
months and annually through 3 years.  MACE is a composite 
endpoint defined as cardiac death, target vessel MI, and clinically-
indicated target lesion revascularization  
• Acute Success including Device and Procedure Success 
• Clinically-indicated Target Lesion and Target Vessel 
Revascularization (CI-TLR and CI-TVR) at 1, 6, and 12 months 
and annually to 5 years for all main study patients and for LP1 
patients at 1, 6, and 12 months and annually through 3 years  
• Clinically-indicated Target Lesion and Target Vessel Failure (CI-
TLF and CI-TVF) at 1, 6, and 12 months and annually to 5 years 
for all main study patients and for LP1 patients at 1, 6, and 12 
months and annually through 3 years  
•  Scaffold Thrombosis at 1, 6, and 12 months and annually to 5 
years for all main study patients and for LP1 patients at 1, 6, and 
12 months and annually through 3 years 
Angiographic 
Endpoints: 
All patients will undergo angiographic follow-up at 6 months.  In a subset 
of the first 35 patients enrolled at select sites angiography will also be 
conducted at 24 and/or 36 months.   
The following endpoints will be analyzed: 
• In-scaffold late lumen loss  
• In-scaffold and in-lesion Binary Restenosis (≥ 50%)  
• In-lesion Late Lumen Loss  

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• In-scaffold and in-segment % Diameter Stenosis  
• MLD and % DS post procedure  
• Scaffold Thrombosis  
• Additional parameters may be assessed  
IVUS and OCT 
Endpoints 
 
To provide an assessment of the lesion and stent morphology and stent 
strut composition over time, the additional imaging modalities of IVUS 
and OCT conducted at baseline, 6 and 24 and/or 36 months will be 
completed in a subset of the first 35 patients enrolled at select sites.  The 
following endpoints will be analyzed: 
• Volumetric neointimal burden by IVUS  
• Changes in vessel size by IVUS 
• Changes in scaffold size by IVUS 
• Changes in strut appearance suggesting bioresorption 
• Incomplete scaffold apposition, acute and late, assessed by IVUS 
and/or Optical Coherence Tomography (OCT)  
• Scaffold area assessed by IVUS and/or OCT  
• Descriptive analysis of lesion/vessel morphormetry and scaffold 
strut composition by OCT  
MSCT 
Analysis Endpoint 
In a subset of the first 35 patients enrolled at select sites, MSCT follow-up 
will be conducted at 12 months.  The following endpoints will be 
analyzed: 
• Multi-slice computed tomography (MSCT) descriptive and 
quantitative analysis of lesion/vessel and scaffold morphology   
Treatment Strategy 
• Treatment of up to two de novo native coronary artery lesions 
located in separate epicardial territories. One will be the target 
lesion and will be treated with the trial device.   

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• Treatment of the target lesion is to be performed after optimal 
stenting using an approved ‘olimus DES of a single non-target 
lesion as applicable.  
• To determine patient eligibility, assessment of the target vessel 
diameter using on-line QCA must be completed before the 
enrollment of the patient into the study.  The target lesion is to be 
treated only after all clinical and angiographic inclusion criteria 
have been met 
• Pre-dilatation of the lesion is mandatory using a balloon 
approximately sized to the reference vessel.  If the lesion cannot be 
successfully pre-dilated, treatment with the DESolve CSS should 
not be attempted. If there is Type A dissection that cannot be 
covered by the DESolve CSS then the patient cannot be enrolled in 
the trial.  Any dissection worse than Type A will preclude the 
patient from being enrolled into the study.  
• Target lesion length should be ≤ 10 mm or ≤ 24 mm by visual 
estimate and have at least 2 mm of healthy vessel on either side of 
the lesion for coverage by the DESolve Scaffold 
Table 1:  Lesion length, Scaffold size and Drug dose 
Lesion length        
(visual estimation) 
DESolve Stent size 
Drug dose 
≤ 10 mm 
3.0 x 14 mm  
3.25 x 14 mm 
3.5 x 14 mm 
65 mcg 
≤ 14 mm 
3.0 x 18 mm  
3.25 x 18 mm 
3.5 x 18 mm 
85 mcg 
≤ 24 mm 
3.0 x 28 mm 
3.25 x 28 mm 
3.5 x 28 mm 
125 mcg 

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• Bailout stenting should be conducted using any approved DES 
stent incorporating an “olimus” drug or bare metal stent 
• Patients should receive a loading dose of clopidogrel (≥ 300 mg) 
and aspirin (≥ 300 mg) if not currently on chronic anti-platelet 
therapy 24 hrs prior to the index procedure.  Patients should 
remain on 75mg of clopidogrel daily for at least 12 months and on 
≥ 75 mg of aspirin indefinitely or at least for the length of the 
study follow-up period of 5 years. 
• All patients will undergo angiography at the 6 month follow-up.   
• IVUS and OCT will be conducted at baseline, 6 and 24 and/or 36 
months in a subset of the first 35 patients enrolled at select sites. 
This subset of patients will also undergo angiography at the 24 
and/or 36 month follow-up. 
• Multislice computed tomography (MSCT) will be conducted will 
be conducted at 12 months in the subset of the first 35 patients 
enrolled at select sites. 
Key Inclusion 
Criteria 
Patients have a planned intervention of up to two native coronary artery 
lesions located in separate epicardial territories, one designated the target 
lesion and the other a non-target lesion, which meet the following criteria: 
The non-target lesion must be treated first using a single, approved 
‘olimus drug eluting stent.  If uncomplicated and considered optimal as 
defined by below, the target lesion can then be treated.  
Optimal treatment of non-target lesion: 
a. < 20% residual stenosis by visual assessment  
b. no evidence of dissection  
c. no evidence of thrombus in the target lesion or vessel 
d. TIMI 3 flow 
No other restrictions are placed on the non-target lesion. The patient and 
target lesion must meet all patient inclusion criteria and no exclusion 
criteria.  
Target Lesion inclusion criteria:  

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• de novo 
• The target lesion reference site must be between  ≥ 2.75 mm and      
≤ 3.5 mm in diameter assessed by online QCA  
• The target vessel must be a major coronary artery or major branch 
with a visually estimated stenosis of ≥ 50% and <100% with TIMI 
flow of ≥ 1 
• The visually estimated target lesion length is ≤ 10mm or ≤ 14 mm 
and must be able to be covered by a single 14 mm or 18 mm 
DESolve®  Scaffold 
• Percutaneous intervention of lesions in a non-target vessel if: 
o Not part of a another clinical investigation 
o ≥ 30 days prior to the study index procedure 
o ≥ 9 months after the study index procedure (planned) 
o Treatment of a single, non-target lesion located in a separate 
major epicardial vessel (defined as LAD with septal and 
diagonal branches, LCX with obtuse marginal and/or ramus 
intermedius branches and RCA and any of its branches) 
attempted during the index procedure must be completed first 
using an approved ‘olimus drug eluting stent.  If the procedure 
is deemed uncomplicated and optimal, treatment of the target 
lesion with the DESolve scaffold can be considered. 
• Percutaneous intervention of lesions in the target vessel if: 
o Not part of a clinical investigation 
o ≥ 6 months prior to the study index procedure 
o ≥ 9 months after the study index procedure (planned) 
o Previous intervention was distal to and >10mm from the 
target lesion 
• The patient must be an acceptable candidate for coronary artery 
bypass surgery 

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Key Exclusion 
Criteria 
Patients must not have any of the following:  
• An untreated significant lesion of > 40% diameter stenosis 
remaining proximal or distal to the target site after the planned 
intervention 
• The lesion is aorto-ostial in location, an unprotected left main 
lesion, a lesion within 5 mm of the origin of the LAD or LCX, or 
involves a major side branch < 2mm in diameter 
• Previous placement of a stent proximal to or within 10 mm of the 
target lesion  
• Total occlusion or < TIMI 1 coronary flow in the target vessel 
• The proximal target vessel or target lesion contains thrombus, 
moderate to severe calcification  or exhibits severe tortuosity (≥ 
45o angulation) by visual assessment 
• High probability that treatment other than PTCA or stenting will 
be required for treatment of the same lesion 
• Patient is a woman of childbearing potential, pregnant or nursing 
• Patient has received brachytherapy in an epicardial vessel 
• Any use of rotablator at the index procedure  
• The patient was diagnosed with an acute myocardial infarction 
(AMI) within the past 72 hours and the CK and CKMB have not 
returned to normal and the  patient is experiencing clinical 
symptoms indicative of ongoing ischemia  
Statistical Analysis 
Analysis Populations in this observational study.   
Modified-Intent-to-Treat Evaluable Population  
The modified-intent-to-treat evaluable population will consist of patients 
who have received the investigational device at the target lesion, who have 
no major procedural protocol deviations (e.g. scaffold implanted in a non-
native coronary artery), no bailout scaffolding and for whom follow-up data 
is available.  

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Intent-to-Treat Population  
The intent-to-treat population will consist of all patients enrolled in the 
study, regardless of the treatment actually received for the target lesion.  
Statistical Analyses  
Detailed descriptive analyses of endpoints will be performed after each 
follow-up time point. No effort will be made to impute or extrapolate data 
to replace missing values. All calculations will be based on available data 
with missing data excluded. Any unused or spurious data will be noted as 
appropriate in the final report.   
All clinical, angiographic, IVUS and OCT endpoints will be analyzed for 
the modified-intent-to-treat evaluable population. Descriptive statistics will 
be presented.  
For binary variables such as MACE, ABR, TLR, TVF, and persistent 
incomplete apposition of the scaffold, counts, percentages, and exact 95% 
confidence intervals using Clopper-Pearson’s method will be calculated.  
For continuous variables, means, standard deviations, and 95% confidence 
intervals for the mean using the Gaussian approximation will be calculated. 
If the assumption of normality seems untenable, nonparametric summary 
statistics will be presented instead.  
For time-to-event variables, such as time to TVF, survival curves will be 
constructed using Kaplan-Meier estimates.