Physician Initiated, Prospective, Non-randomized Belgian Multi-center Trial, Investigating the Safety and Efficacy of the Treatment With the LumINor DCB and The IvolutioN Stent of iVascular in TASC C and D Femoropopliteal Atherosclerotic Disease
Phase: NA
Conditions: Peripheral Arterial Disease
Sponsor: ID3 Medical

NCT03347383   Unique Protocol ID: ID3­20170628 
ID3­20200323 
 
T.I.N.T.I.N. study 
PROTOCOL SYNOPSIS v2.0 
23­MAR­ 2020 
1/4 
 
 
T.I.N.T.I.N. STUDY 
PROTOCOL SYNOPSIS 
V2.0- 20200323 
 
 
Title 
T.I.N.T.I.N.: Physician initiated, prospective, non-randomized Belgian multi-
center trial, Investigating the safety and efficacy of the Treatment with the 
LumINor DCB and The IvolutioN stent of iVascular in TASC C and D 
femoropopliteal atherosclerotic disease 
 
Objective 
The objective of this clinical investigation is to evaluate the long-term (up to 5 
years)outcome of the combination therapy with the Luminor DCB and the 
iVolution stent of iVascular for the treatment of long femoropopliteal lesions 
(TASC C & D) 
 
Methodology 
Prospective, multi-center, physician initiated clinical study 
 
Enrollment 
100 subjects 
 
Primary Endpoint 
Efficacy endpoint: Freedom from clinically-driven TLR at 12 months: TLR 
defined as a repeated intervention to maintain or re-establish patency within 
the region of the treated arterial vessel plus 5mm proximal and distal to the 
treated lesion edge at the respective time points 
 
Secondary  
Endpoints 
1. 
Primary patency rate at 6- and 12-month follow-up; defined as absence of 
a hemodynamically significant stenosis on duplex ultrasound (systolic 
velocity ratio no greater than 2.5) at the target lesion and without TLR 
within the time of procedure and the given follow-up.  
2. 
Technical success; defined as the ability to cross and dilate the lesion and 
achieve residual angiographic stenosis no greater than 30% 
3. 
Freedom from clinically-driven TLR at 6-month, 2, 3, 4 and 5 year follow-
up; TLR defined as a repeated intervention to maintain or re-establish 
patency within the region of the treated arterial vessel plus 5mm 
proximal and distal to the treated lesion edge at the respective time 
points 
4. 
Clinical success at follow-up; defined as an improvement of Rutherford 
classification at all follow-up time points of one class or more as 
compared to the pre-procedure Rutherford classification 
5. 
Serious adverse events as defined per ISO 14155:2011 
 
Inclusion Criteria 
1. 
Patient presenting a score from 2 to 5 following Rutherford classification 
2. 
Patient is willing to comply with specified follow-up evaluations at the 
specified times  
3. 
Patient is >18 years old  
4. 
Patient understands the nature of the procedure and provides written 
informed consent, prior to enrolment in the study  
5. 
Patient has a projected life expectancy of at least 12 months  
6. 
Prior to enrolment, the guidewire has crossed target lesion  

NCT03347383   Unique Protocol ID: ID3­20170628 
ID3­20200323 
 
T.I.N.T.I.N. study 
PROTOCOL SYNOPSIS v2.0 
23­MAR­ 2020 
2/4 
 
7. 
Patient is eligible for treatment with the Luminor Paclitaxel-Eluting 
Peripheral Balloon Dilatation Catheter and the iVolution stent 
8. 
Male, infertile female or female of child bearing potential practicing an 
acceptable method of birth control with a negative pregnancy test within 
7 days prior to study procedure 
 
Angiographic 
Inclusion Criteria 
1. 
De novo and post-PTA restenotic lesions located in the femoropopliteal 
arteries suitable for endovascular therapy 
2. 
The target lesion is located within the native femoropopliteal artery 
3. 
The length of the target lesion is ≥ 150mm and considered as TASC C or D 
lesion according to the TASC II classification. 
4. 
The target lesion has angiographic evidence of stenosis > 50% or 
occlusion which can be passed with standard guidewire manipulation 
5. 
Target vessel diameter visually estimated is >4mm and <6.5 mm 
6. 
There is angiographic evidence of at least one-vessel-runoff to the foot, 
irrespective of whether or not outflow was re-established by means of 
previous endovascular intervention 
 
Exclusion Criteria 
1. 
Patient refusing treatment 
2. 
Presence of a stent in the target lesion that was placed during a previous 
procedure 
3. 
Untreated flow-limiting inflow lesions 
4. 
Any previous surgery in the target vessel (including prior ipsilateral crural 
bypass) 
5. 
Patients for whom antiplatelet therapy, anticoagulants or thrombolytic 
drugs are contraindicated  
6. 
Patients who exhibit persistent acute intraluminal thrombus of the 
proposed lesion site  
7. 
Perforation at the angioplasty site evidenced by extravasation of contrast 
medium  
8. 
Patients with known hypersensitivity to heparin, including those patients 
who have had a previous incidence of heparin-induced thrombocytopenia 
(HIT) type II  
9. 
Patients with uncorrected bleeding disorders  
10.  Aneurysm located at the level of the SFA/popliteal artery 
11.  Non-atherosclerotic disease resulting in occlusion (e.g. embolism, 
Buerger’s disease, vasculitis) 
12.  Severe medical comorbidities (untreated CAD/CHF, sever COPD, 
metastatic malignancy, dementia, etc.) or other medical condition that 
would preclude compliance with the study protocol or 1-year life 
expectancy  
13.  Major distal amputation (above the transmetatarsal) in the study limb or 
non-study limb  
14.  Septicemia or bacteremia  
15.  Use of thrombectomy, atherectomy or laser devices during procedure  
16.  Any patient considered to be hemodynamically unstable at onset of 
procedure  
17.  Known allergy to contrast media that cannot be adequately pre-
medicated prior to the study procedure 
 
P.I. 
Dr. Koen Deloose, A.Z. Sint-Blasius, Dendermonde 

NCT03347383   Unique Protocol ID: ID3­20170628 
ID3­20200323 
 
T.I.N.T.I.N. study 
PROTOCOL SYNOPSIS v2.0 
23­MAR­ 2020 
3/4 
 
 
Study conduct 
The study will be conducted in accordance with the Declaration of Helsinki and 
ISO 14155:2011, and comply with requirements regarding Ethics Committees 
and any other applicable regulations. 
Study 
investigations 
Time  
 
Tests and Procedures 
Pre-Procedure 
(up to 24 hours before 
procedure, unless 
otherwise noted) 
1. 
2. 
3. 
4. 
Medical History 
Medication Registration 
Physical Exam (ABI, Rutherford) 
Consenting patient 
Procedure 
1. 
2. 
3. 
4. 
5.  
Angiography, pre–procedure  
Study inclusion 
Intervention details 
Angio post-procedure 
Adverse Event recording/reporting  
1 day Post-Procedure  
1. 
2. 
3. 
Medication Registration 
Physical Examination (ABI, Rutherford) 
Adverse Event recording/reporting 
1 month Follow-up  
( 7 days) 
1. 
2. 
3. 
4. 
Medication Registration 
Physical Examination (ABI, Rutherford) 
Color Flow Doppler Ultrasound 
Adverse Event recording/reporting 
6 month Follow-up  
( 30 days) 
1. 
2. 
3. 
4. 
Medication Registration 
Physical Examination (ABI, Rutherford) 
Color Flow Doppler Ultrasound 
Adverse Event recording/reporting 
 12 month Follow-up  
( 30 days) 
1. 
2. 
3. 
4. 
Medication Registration 
Physical Examination (ABI, Rutherford) 
Color Flow Doppler Ultrasound 
Adverse Event recording/reporting 
 2 year Follow-up  
( 30 days) 
1. 
2. 
3. 
Medication Registration 
Physical Examination (ABI, Rutherford) 
Adverse Event recording/reporting 
 3 year Follow-up  
( 30 days) 
1. 
2. 
3. 
Medication Registration 
Physical Examination (ABI, Rutherford) 
Adverse Event recording/reporting 
 4 year Follow-up  
( 30 days) 
1. 
2. 
3. 
Medication Registration 
Physical Examination (ABI, Rutherford)Adverse Event 
recording/reporting 
 5 year Follow-up  
( 30 days) 
1. 
2. 
   3. 
Medication Registration 
Physical Examination (ABI, Rutherford) 
Adverse Event recording/reporting 
 
Participating sites 
 
• 
Dr Deloose, AZ Sint-Blasius, Dendermonde, Belgium 
• 
Dr Maene, OLV-ziekenhuis, Aalst, Belgium 
• 
Dr. Keirse, RZ Tienen, Tienen, Belgium 
• 
Dr Goverde, ZNA Stuivenberg, Antwerp, Belgium 
• 
Dr. Verbist, Imelda, Bonheiden, Belgium 
• 
Dr. Schepers, AZ Damiaan, Oostende, Belgium 
• 
Dr. Dubois, Heilig Hartziekenhuis, Lier, Belgium 
• 
Dr. Balduyk, Sint Jozefkliniek, Bornem, Belgium 
• 
Dr. Robijn, AZ Jan Portaels ziekenhuis, Vilvoorde, Belgium 
 
 
 

NCT03347383   Unique Protocol ID: ID3­20170628 
ID3­20200323 
 
T.I.N.T.I.N. study 
PROTOCOL SYNOPSIS v2.0 
23­MAR­ 2020 
4/4 
 
Statistical Analysis Plan (SAP)  
 
Descriptive data summaries will be used to present and summarize the collected data. For categorical 
variables (e.g. Gender) frequency distributions and cross tabulations will be given. For numeric 
variables (e.g. Patient age) minimum, maximum, mean, median and standard deviation will be 
calculated. For all variables a 95% confidence interval for the relevant parameters of the underlying 
distribution will be calculated. For all time-dependent events life-tables will be calculated using the 
Kaplan Meier estimate method, for a period starting on the date of the procedure up to and 
including the 12-month follow-up visit. Stratification to pre-procedural risk factors, Rutherford and 
lesion criteria will be performed and the log rank test will be used to compare between the different 
outcomes, associated p-values < 0.05 are defined as significant.