Safety Assessment of Angioplasty Procedures
Conditions: Angiospastic; Disorder
Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

 
 
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Assessment of the safety of Angioplasty procedures 
SCRAP 
2018/P02/283 
 
NON-INTERVENTIONAL RESEARCH PROTOCOL INVOLVING THE HUMAN PERSON 
 
Version No.3.0 from20/02/2021 
RCB-ID number: 2018-A03472-53 
NCT03893396 
 
 
 
 
 
Sponsor 
Hospital Group of La Rochelle Ré Aunis 
Dr. Schweizer Street 
17019 La Rochelle 
 
Person who directs and monitors research: 
Dr. Ludovic MEUNIER 
Cardiology service 
Hospital Group La Rochelle-Ré-Aunis 
Dr. Schweitzer Street 
17019 LA ROCHELLE 
 
 
Center for Methodology and Data Management: 
Clinical research unit 
Hospital Group of La Rochelle Ré Aunis 
Dr. Schweizer Street 
17019 La Rochelle 
 
 
 
 
 
 
This protocol was designed and drafted from version 3.0 of 01/02/2017 
of the GIRCI SOHO standard protocol
 Translated from French to English - www.onlinedoctranslator.com 

 
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PROTOCOL UPDATE HISTORY 
 
VERSION 
DATE 
REASON FOR UPDATE 
1.0 
26/12/2018 
Initial version 
2.0 
02/11/2019 
Request for information or modifications 
3.0 
02/20/2021 
Amendment request for study extension 
 
 
 
 
 

 
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SUMMARY 
 
 
ABREVIATIONS LIST 
 
ARCClinical research associate  
 
StrokeCerebrovascular accident  
 
ANSMNational Agency for the Safety of Medicines and Health Products 
 
 
CPPCommittee for the Protection of Persons 
 
 
EMAEuropean Medicines Agency 
 
 
MACEMajor Adverse Cardiac Events  
 
TECClinical research technician 
 
 
 
 

 
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SUMMARY OF RESEARCH 
PROMOTER 
Hospital Group of La Rochelle Ré Aunis 
Dr. Schweizer Street 
17019 La Rochelle 
PERSON 
LEADING THE 
RESEARCH 
Dr. Ludovic MEUNIER 
Cardiology service 
Hospital Group La Rochelle-Ré-Aunis 
TITLE 
SAFETY EVALUATION OF ANGIOPLASTY INTERVENTIONS (SCRAP) 
RATIONALE/CON
TEXT 
Ischemic heart disease, or coronary heart disease, covers a set of pathologies due to 
insufficient oxygen supply to the myocardium due to the development of atherosclerosis 
in one or more coronary arteries. The use of active stents for the treatment of coronary 
stenosis is currently the standard treatment in almost all types of coronary lesions. In 
the percutaneous transluminal treatment of coronary lesions, angioplasty with balloons 
and bare stents has not shown satisfactory results in the past. The drug-eluting, so-called 
active balloon, could represent a new therapeutic option for the treatment of de novo 
lesions. 
GOALS 
To assess the safety of angioplasties performed in patients operated on at La Rochelle 
Hospital, the rate of major adverse cardiac events (MACE) will be determined and 
analyzed in the light of data from the literature. 
RESEARCH 
SCHEME 
non-interventional, prospective, monocentric research. 
INCLUSION 
CRITERIA 
 
Patient treated for angioplasty, 
 
Person affiliated or beneficiary of a social security scheme, 
 
Informed about the study. 
NON-INCLUSION 
CRITERIA 
 
language barrier, 
 
Minor, 
 
Pregnant woman, 
 
Person under guardianship or 
curatorship, 
 
person deprived of liberty, 
 
Refusal to participate. 
EVALUATION 
CRITERIA 
The primary endpoint is a composite endpoint of major adverse cardiac events defined 
as death, nonfatal myocardial infarction (MI), nonfatal stroke (stroke), and target lesion 
revascularization (TLR) within 12 monthsthen at 36 monthsfollowing the intervention. 
STUDY SIZE 
The objective is to include more than 80% of patients over a period of 12 months, ie 
1000 patients. 
SEARCH 
DURATION 
 Duration of the inclusion period: 12 months 
 Duration of follow-up per participant:36months (telephone contact at 12 
monthsthen at 36 monthsfor MACE collection) 
 Total search time:48 month 
STATISTICAL 
ANALYSIS OF 
DATA 
The parameters collected are presented in tables containing descriptive and comparative 
statistics (total population; small vessel/large vessel subpopulations; stent[s]/stent[s] 
and active balloon[s]/active balloons subpopulations assets]). The MACE rate 
corresponds to the ratio of the number of patients who had one or more MACE to the 
total number of patients for whom the follow-up was carried out at 12 monthsthen 
to36month. The study of risk factors for MACE is carried out by bivariate analysis. 
EXPECTED 
BENEFITS 
The results of this study will make it possible to validate or not the algorithm of care 
applied to the hospital of La Rochelle. The results will be communicated to the 
Coronary Atheroma and Interventional Cardiology Group (GACI). 

 
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 SCIENTIFIC RATIONALE AND GENERAL DESCRIPTION 
CURRENT STATE OF KNOWLEDGE 
Ischemic heart disease, or coronary heart disease, covers a set of pathologies due to insufficient oxygen 
supply to the myocardium due to the development of atherosclerosis in one or more coronary artery(ies). 
The use of active stents for the treatment of coronary stenosis is currently the standard treatment in 
almost all types of coronary lesions. In the percutaneous transluminal treatment of coronary artery 
lesions, balloon angioplasty with conventional balloons and drug-free eluting stents have not shown 
satisfactory results.(1)(2). Although some studies have shown balloon angioplasty and bare stent 
placement to be equally effective against restenosis(1)(2), a meta-analysis of 11 trials finds a rate of 
25.8% for balloon angioplasty and 34.2% for bare-metal stents(3). 
Thrombosis and in-stent restenosis, despite a decreasing incidence since the advent of first and then 
second generation active stents, remain frequent complications of angioplasty at around 5 to 15% 
depending on the series. (4.5). Indeed, the implantation of stents in the arterial wall leads to an 
inflammatory reaction around the mesh as well as the persistence of fibrinous deposits at the origin of a 
neointimal proliferation that is more thrombogenic than the native endothelium. (6). To this is added a 
phenomenon of neoatherosclerosis which appears later than on bare stents, most often 3 years from the 
date of implantation. On the other hand, very late stent thromboses, defined by the Academic Research 
Consortium as occurring more than one year after stent implantation, in fact require prolonged 
observation in order to take them into account. 
The drug-eluting balloon, also called active balloon, or DCB (Drug Coated Balloon), was initially 
developed for the treatment of in-stent restenosis (4), and is currently considered the standard treatment 
for this pathology instead of in-stent active stenting. Since then, the active balloon has gradually been 
studied for the treatment of de novo lesions (5), particularly those of small vessels. The multicenter 
randomized BASKET-SMALL study on small de novo lesions (less than or equal to 2.5 mm in diameter) 
showed the non-inferiority of drug-eluting balloons compared to the active stent with regard to MACE 
up to 12 months, with similar event rates for both treatment groups(7).  
Recently, pilot studies have demonstrated the feasibility of using drug-eluting balloons for the treatment 
of bifurcations(8), chronic occlusions(9), as well as calcified lesions after Rotablator(10). These studies 
have thus shown very promising and consistent results when the active balloon was used as an alternative 
therapy. The German consensus group has therefore recently developed recommendations for the 
treatment of small vessel disease using the drug-eluting balloon(11).The BASKET SMALL 2 study is 
the first study to have compared the effectiveness of the active balloon versus an active stent in the 
treatment of de novo lesions of small vessels, with a fairly long follow-up period of 3 years and in a 
sufficiently large workforce. (12).Other studies have been able to demonstrate good results at 6 months 
in terms of efficacy and safety of the active balloon on the treatment of de novo lesions, regardless of 
the caliber of the vessel treated. (13). However, data are lacking in the literature concerning the treatment 

 
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of de novo lesions by active balloon, with a sufficiently long follow-up period to take into account neo-
atheromatosis and very late stent thrombosis, in a large sample. 
The use of drug-eluting balloons in La Rochelle has gradually evolved from the in-stent indication, to 
de novo lesions of small vessels (≤ 2.5 mm), then to de novo lesions of large vessels. In addition to the 
treatment of long lesions on small caliber vessels, good immediate angiographic results are also obtained 
for the treatment of bifurcations (all types of Medina), for calcified lesions pretreated with Rotablator, 
as well as certain chronic occlusions. 
 
RESEARCH ASSUMPTIONS 
To assess the safety of angioplasties performed in patients operated on at La Rochelle Hospital, the rate 
of major adverse cardiac events (MACE) will be determined and analyzed in the light of data from the 
literature. 
 
 
JUSTIFICATION OF METHODOLOGICAL CHOICES 
The collection of data on MACE will be carried out by telephone follow-up at 12 monthsthen at 36 
months. Major adverse cardiac events are defined as death, myocardial infarction, and ischemia-induced 
target lesion revascularization during the follow-up period. 
 
EXPECTED BENEFITS 
The results of this study will make it possible to validate or not the algorithm of care applied to the 
hospital of La Rochelle. 
The results will be communicated to the Coronary Atheroma and Interventional Cardiology Group 
(GACI). 
 
 

 
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GOALS 
1.1. PRIMARY OBJECTIVE 
To assess the safety of angioplasties performed in patients operated on at La Rochelle Hospital, these 
will be referred to as 12 monthsthen at 36 monthsafter the operation to find out if any major adverse 
cardiac events (MACE) have occurred since their operation. The MACE rate will thus be determined. 
 
 
RESEARCH DESIGN 
This is non-interventional, cross-sectional, prospective, monocentric research. 
 
 
 
 
ELIGIBILITY CRITERIA 
1.2. INCLUSION CRITERIA 
 
Patient treated for angioplasty, 
 
Person affiliated or beneficiary of a social security scheme, 
 
Informed about the study. 
NON-INCLUSION CRITERIA 
 
language barrier, 
 
Minor, 
 
Pregnant woman, 
 
Person under guardianship or curatorship, 
Phone call at 36month 

 
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 
Persons deprived of liberty, 
 
Refusal to participate. 
FEASIBILITY AND MODALITIES OF RECRUITMENT 
Participants will be selected from the Cardiology department of the Saint Louis Hospital of the La 
Rochelle-Ré-Aunis Hospital Group. 
 
PROCEDURES STUDIED 
Patients referred for coronary angiography for revascularization are those diagnosed with acute coronary 
disease (Acute Coronary Syndrome with or without ST segment elevation) or chronic (silent myocardial 
ischemia, angina). 
 
During coronary angiography, significant lesions are those for which the percentage of stenosis in 
relation to the reference diameter is ≥ 50-70%. 
In case of angiographic doubt as to the significance of a lesion, an FFR (Fractional Flow Reserve) can 
be performed. A value less than or equal to 0.80 is thus in favor of a hemodynamically significant lesion. 
 
Depending on the terrain, the number and the characteristics of the lesions, the patient is offered a 
strategy of surgical revascularization by bypass or interventional by angioplasty. 
When the interventional strategy is chosen, the angioplasty of one or more lesions can be performed in 
one or more stages using stents (generally active) and/or active balloons. 
 
The choice between stenting (active/naked) and active balloon is based on the following criteria: 
 
Active stenting: 
o hemodynamic instability, malignant ventricular hyperexcitability (VT, VF), plurivessel 
with altered LVEF, 
o extensive or sub-occlusive type C, D or E dissection or persistence of ≥ 50% stenosis 
after predilation. 
 
Active balloon: residual stenosis ≤ 30% and absence of extensive or sub-occlusive type C, D or 
E dissection after predilation(14), patient at risk of hemorrhage. 
 
Naked stenting: extensive or occlusive dissection after active balloon, 
 
 

 
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Figure 1: diagram of the strategy of revascularization by angioplasty. 
* In case of haemodynamic/rhythmic instability; FFR: Fractional Flow Reserve 
 
 
EVALUATION CRITERIA 
The primary endpoint is a composite endpoint of major adverse cardiac events defined as death, nonfatal 
myocardial infarction (MI), nonfatal stroke (stroke), and target lesion revascularization (TLR) within 12 
monthsthen 36 monthsfollowing the intervention. 

 
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PROCEDURE OF THE RESEARCH 
RESEARCH TIMELINE 
- Duration of the inclusion period: 12 months 
- Duration of follow-up per participant:36months (telephone contact at 12 monthsthen at 36 
monthsfor MACE collection) 
- Total search time:48month 
 
SUMMARY TABLE OF PARTICIPANT MONITORING 
 
Screening Inclusion 
Phone contact 
Phone contact 
 
D-28 to 
D-1 
D0 
M12 +/- 30 days 
M36 +/- 30 days 
Verification of eligibility criteria 
X 
X 
 
 
Presentation of the study 
X 
X 
 
 
Compendium of non-opposition 
 
X 
 
 
MACE collection 
 
 
X 
X 
 
 
INFORMATION OF DATA SUBJECTS 
The doctor offers the patient to participate in this research and informs him: 
‐ 
of the objective, 
‐ 
of the computerized processing of the data concerning him which will be collected during this 
research and also specifies his rights of access, opposition and rectification to this data. 
The doctor also checks the eligibility criteria. If the person agrees to participate, they give their consent 
orally and their non-objection is documented in their medical file. The participant may, at any time, 
oppose the use of his data, within the framework of the research. 
The non-objection is collected before the patient leaves hospital. 
FOLLOW-UP VISITS  
Patients who have agreed to participate will be contacted one yearthen three yearsafter their intervention 
by telephone. 
In case of MACE, the patient's cardiologist will be contacted for the detailed record of the event. 
 

 
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STATISTICAL ASPECTS 
STUDY SIZE CALCULATION 
In 2017, the La Rochelle cardiology department treated 1,252 patients for coronary pathologies. The 
objective is to include more than 80% of patients over a period of 12 months, ie 1000 patients. 
1.3. STATISTICAL METHODS USED 
The parameters collected are presented in tables with descriptive statistics for the total population and 
for the sub-populations defined by the size of the vessels (small vessels / large vessels) or the procedure 
used (active stent[s] / stent [s] and balloon[s] active[s] / balloon[s] active[s]), according to the following 
modalities: 
‐ 
For quantitative variables: the mean and the standard deviation or the median, the minimum and 
the maximum 
‐ 
For qualitative variables: the number, percentages and 95% confidence interval, for each of the 
modalities of the variable (excluding missing data in the denominator). 
 
The MACE rate will correspond to the ratio of the number of patients having had one or more MACE 
to the total number of patients for whom the follow-up was carried out at 12 months.then at 36 months. 
 
To compare the sub-populations, the analyzes test the null hypothesis of equality of means for the 
quantitative variables and of homogeneity of the populations for the qualitative variables: 
‐ 
For the quantitative variables, after checking the equality of the variances and the normal 
distribution of the values, the Student test is used. In case of inequality of variances or non-
Gaussian distribution, a non-parametric Mann-Whitney/Wilcoxon test is used. 
‐ 
For qualitative variables, a chi-square test is carried out or a Fisher test in the case of small 
numbers. 
The study of risk factors for MACE is carried out by bivariate analysis. Odds ratios and 95% confidence 
intervals are calculated. 
 
 
ACCESS RIGHTS TO SOURCE DATA AND DOCUMENTS 
ACCESS TO DATA 
The acceptance of participation in the protocol implies that the people carrying out the research will 
make available the documents and individual data strictly necessary for the monitoring, quality control 

 
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and audit of the research, available to people with access to these documents in accordance with the 
laws and regulations in force. 
SOURCE DATA 
All information contained in original documents, or in authenticated copies of these documents, relating 
to clinical examinations, observations or other activities carried out in the context of research and 
necessary for the reconstitution and evaluation of the research. The documents in which source data is 
stored are called source documents. 
 
Source documents: 
- Hospital medical record 
- Report of consultation of city cardiologists 
DATA PRIVACY 
In accordance with the legislative provisions in force, the persons having direct access to the source data 
will take all the necessary precautions to ensure the confidentiality of the information relating to the 
research, to the persons who lend themselves to it and in particular with regard to their identity as well 
as only to the results obtained. These people, in the same way as the people who direct and monitor the 
research, are subject to professional secrecy. 
During the research or at its end, the data collected on the people who agree to it and transmitted to the 
promoter by the people who direct and monitor the research (or any other specialized contributors) will 
be codified. Under no circumstances should they clearly show the names of the persons concerned or 
their addresses. 
The name of the patients will be coded by: Initial surname – initial first name – inclusion number 
(Example: Bertrand DUPOND, 65th inclusion  BD65) 
The promoter will ensure that each person who agrees to the research has been informed of access to 
the individual data concerning him and strictly necessary for the quality control of the research. 
 
QUALITY CONTROL AND ASSURANCE 
RESEARCH FOLLOW-UP 
The follow-up of the research will be ensured by a health manager. He will be responsible, 
alongside the person directing and supervising the research, for: 
- 
research logistics and monitoring, 

 
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- 
drawing up reports on its progress, 
- 
verification of the update of the observation book (request for additional information, 
corrections, etc.). 
He will work in accordance with standard operating procedures, in collaboration with the 
clinical research associate delegated by the promoter. 
 
QUALITY CONTROL 
A clinical research associate mandated by the sponsor visits the center on a regular basis, during the 
setting up of the research, one or more times during the research depending on the rhythm of inclusions 
and at the end of the research. During these visits, the following elements will be reviewed: 
- 
compliance with the research protocol, 
- 
quality of data collected in the case report: accuracy, missing data, consistency of data with 
source documents (medical records, appointment books, original laboratory results, etc., etc.). 
Any visit will be the subject of a monitoring report in written form. 
 
DATA MANAGMENT 
CardioReport software will be used for data entry at inclusion. An extraction will create an Excel table 
to program and record the monitoring data at 12 monthsand at 36 monthsfor the census of MACE. The 
final database will be pseudonymised. 
The person responsible for hosting and maintaining the database is the Groupe Hospitalier de la Rochelle 
Ré Aunis. The server hosting the data is located in the IT department. 
Daily backups are performed on discs, the storage location is subject to access control and benefits from 
fire protection. 
Authorization profiles define the functions or types of information accessible to a user. The logical 
access control is done by a password (8 characters minimum, 1 capital letter compulsory; validity: 2 
months). A procedure defines the distribution of access control means to authorized persons, the 
allocation by the software administrator and specifies the written traceability of the request. 
The shelf life is defined in the study protocol. The current archives are kept in the service until the results 
are published. Intermediate archives are kept according to legal provisions in the archive room dedicated 
to clinical research. 
 

 
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AUDITING AND INSPECTION 
An audit may be carried out at any time by persons appointed by thepromoter andindependent of the 
people conducting the research. Its purpose is to verify the security of the participants and the respect of 
their rights, the respect of the applicable regulations and the reliability of the data. 
An inspection can also be carried out by a competent authority (ANSM for France or EMA within the 
framework of a European test for example). 
The audit, as well as the inspection, could apply to all stages of research, from the development of the 
protocol to the publication of the results and the classification of the data used or produced within the 
framework of the research. 
 
Investigators agree to comply with the sponsor's requirements for an audit and the competent authority 
for an inspection of the research. 
 
ETHICAL AND REGULATORY CONSIDERATIONS 
COMPLIANCE WITH REFERENCE TEXTS 
The promoter and the person(s) directing and supervising the research undertake to ensure that this 
research is carried out in accordance with law no. 2012-300 of March 5, 2012 relating to research. 
involving the human person and the declaration of Helsinki (which can be found in its integral version 
on the sitehttp://www.wma.net/en/30publications/10policies/b3/). 
 
This research has received the favorable opinion of the Committee for the Protection of Persons (CPP) 
Sud-Est VI. 
 
The data recorded during this research is subject to computerized processing at the Groupe Hospitalier 
de la Rochelle-Ré-Aunis in compliance with law n ° 78-17 of January 6, 1978 relating to data processing, 
files and freedoms amended by law 2004-801 of August 6, 2004. 
 
This research is part of the “Reference Methodology” (MR-003). The La Rochelle-Ré-Aunis Hospital 
Group has signed a commitment to comply with this "Reference Methodology". 
AMENDMENTS TO PROTOCOL 
Any substantial modification, i.e. any modification likely to have a significant impact on the protection 
of persons, on the conditions of validity and on the results of the research, on the quality and safety of 
the products tested, on the interpretation of the scientific documents that support the progress of the 

 
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research or the methods of conducting it, is the subject of a written amendment which is submitted to 
the sponsor; the latter must obtain, prior to its implementation, a favorable opinion from the CPP. 
 
Non-substantial modifications, ie those having no significant impact on any aspect of the research 
whatsoever, are communicated to the CPP for information. 
 
All modifications are validated by the sponsor, and by all the research stakeholders concerned by the 
modification, before submission to the CPP. This validation may require the meeting of any committee 
set up for the research. . 
 
All modifications to the protocol must be brought to the attention of all the people carrying out the 
research, who undertake to respect its content. 
 
PRESERVATION OF DOCUMENTS AND DATA RELATING TO RESEARCH 
The following documents will be archived by the service until the end of the period of practical 
usefulness. This indexed archive includes: 
 
Mail copies of the CPP notice 
 
The successive versions of the protocol (identified by the version number and the version 
date), 
 
The pseudonymised database, 
 
All appendices specific to the study, 
 
The final study report from the statistical analysis and quality control of the study (duplicate 
sent to the sponsor). 
 
Any audit certificates produced during the research 
 
The database that gave rise to the statistical analysis must also be archived by the person in charge of 
the analysis (paper or electronic medium). 
At the end of the period of practical usefulness, all the documents to be archived, as defined in the 
procedure for "classification and archiving of documents related to biomedical research" of the Groupe 
Hospitalier de la Rochelle Ré Aunis will be transferred to the archiving site dedicated to clinical research 
and will be placed under the responsibility of the Sponsor for 15 years after the end of the study in 
accordance with institutional practices. 
No displacement or destruction can be carried out without the agreement of the Promoter. At the end of 
the 15 years, the promoter will be consulted for destruction. All data, documents and reports are subject 
to audit or inspection. 

 
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RULES RELATING TO PUBLICATION 
SCIENTIFIC PAPERS 
Any written or oral communication of the results of the research must receive the prior agreement of the 
person directing and supervising the research and, where applicable, of any committee set up for the 
research. 
The publication of the main results mentions the name of the promoter, of all the people who included 
or followed patients in the research, of the methodologists, biostatisticians and data managers who 
participated in the research, of the members of the committee(s) set up( s) for the research and the 
possible participation of the laboratory name of the pharmaceutical laboratory / the source of funding. 
International rules for writing and publication will be taken into account (The Uniform Requirements 
for Manuscripts of the ICMJE, April 2010). 
COMMUNICATION OF RESULTS TO PATIENTS 
At their request, participants in the research are informed of the overall results of the latter. 
TRANSFER OF DATA 
The collection and management of data is provided by the Hospital Group of La Rochelle-Ré-
Aunis. The conditions for the transfer of all or part of the research database are decided by the 
research sponsor and are the subject of a written contract. 
 

 
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BIBLIOGRAPHIC REFERENCES 
1.Kastrati A., Schomig A., Dirschinger J., et al. A randomized trial comparing stenting with balloon 
angioplasty in small vessels in patients with symptomatic coronary artery disease. Circulation 
2000;102(21):2593–8. Doi: 10.1161/01.CIR.102.21.2593. 
 
2. Doucet S., Schalij MJ., Vrolix MCM., et al. Small Coronary Arteries. Small 2001. 
 
3. Moreno R., Fernández C., Alfonso F., et al. Coronary stenting versus balloon angioplasty in small 
vessels: A meta-analysis from 11 randomized studies. J Am Coll Cardiol 2004;43(11):1964–
72. Doi: 10.1016/j.jacc.2004.01.039. 
 
4.Cassese S, Byrne RA, Tada T, et al. Incidence and predictors of restenosis after coronary stenting in 
10,004 patients with surveillance angiography. Heart 2014;100(2):153–9. Doi: 
10.1136/heartjnl-2013-304933.  
5.Torrado J., Buckley L., Durán A., et al. Restenosis, Stent Thrombosis, and Bleeding Complications: 
Navigating Between Scylla and Charybdis. J Am Coll Cardiol 2018;71(15):1676–95. Doi: 
10.1016/j.jacc.2018.02.023. 
 
6.Alfonso F., Byrne RA., Rivero F., Kastrati A. Current treatment of in-stent restenosis. J Am Coll 
Cardiol 2014;63(24):2659–73. Doi: 10.1016/j.jacc.2014.02.545.  
7. Jeger R V, Farah A, Ohlow MA, et al. Drug-coated balloons for small coronary artery disease 
(BASKET-SMALL 2): an open-label randomized non-inferiority trial. Lancet 
2018;392(10150):849–56. Doi: 10.1016/S0140-6736(18)31719-7. 
 
8. Zuin M., Rigatelli G. Treatment of de novo coronary artery bifurcation lesions with drug coated 
balloons: A reappraisal according to the available scientific data. Cardiovascular 
Revascularization Med 2018;19(1):57–64. Doi: 10.1016/j.carrev.2017.07.003. 
 
9.Scheller B., Liew HB., Rissa-TT., et al. Treatment of chronic total occlusions in native coronary 
arteries by drug-coated balloons without stenting - A feasibility and safety study. Int J Cardiol 
2016. Doi: 10.1016/j.ijcard.2016.09.105. 
10.Rissanen TT., Uskela S., Siljander A. Percutaneous Coronary Intervention of Complex Calciated 
Lesions With Drug-Coated Balloon After Rotational Atherectomy 2017;9999(9999):1–8. Doi: 
10.1111/joic.12366. 
 
11.Kleber FX., Mathey DG., Rittger H., Scheller B. How to use the drug-eluting balloon: 
Recommendations by the German consensus group. EuroIntervention 2011;7(SUPPL.K):125–
8. Doi: 10.4244/EIJV7SKA21.  
12. Jeger R V, Farah A, Ohlow MA, et al. Drug-coated balloons for small coronary artery disease 
(BASKET-SMALL 2): an open-label randomized non-inferiority trial. Lancet 
2018;392(10150):849–56. Doi: 10.1016/S0140-6736(18)31719-7. 
 
13.Her AY, Yuan SL, Jun EJ, et al. Drug-coated balloon treatment for nonsmall de-novo coronary 
artery disease: angiographic and clinical outcomes. Coron Artery Dis 2021. Doi: 
10.1097/MCA.0000000000001006. 
 

 
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14.Higeyama JS., To SI., Ondo HK. Angiographic Classification of Coronary Dissections after Plain 
Old Balloon Angioplasty for Prediction of Regression at Follow-up 2001:393–408.