Turbo Power Laser Atherectomy Combined With Drug Coated Balloon Angioplasty for the Treatment of Femoropopliteal De Novo/ Restenotic and In-Stent Restenosis Lesions
Conditions: Peripheral Arterial Disease
Sponsor: Spectranetics Corporation

 
 
 
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Walker TurboPower+DCB Retro 
20Mar2018 
 
 
 
 
 
 
Turbo Power Laser Atherectomy Combined with Drug Coated Balloon Angioplasty for the 
Treatment of Femoropopliteal De Novo/ Restenotic and In-Stent Restenosis Lesions 
  
 
 
Study Protocol 
V2.0 
 
 
 
INVESTIGATOR: Craig Walker, MD 
 
 
 
FUNDING: Investigator-Initiated Study Grant from Spectranetics 
 
 
 

 
 
 
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Walker TurboPower+DCB Retro 
20Mar2018 
 Protocol Summary: 
 
Title: 
Turbo Power Laser Atherectomy Combined with Drug Coated Balloon 
Angioplasty for the Treatment of Femoropopliteal De Novo/ Restenotic and 
In-Stent Restenosis Lesions 
Study 
Objectives: 
To determine outcomes of combined Turbo Power laser atherectomy + drug 
coated balloon (DCB) angioplasty for the treatment of femoropopliteal de 
novo/restenotic lesions and in-stent restenosis (ISR). Better understanding of 
these outcomes will help guide optimal treatment algorithms for this difficult 
to treat cohort of patients. 
Primary 
Endpoint: 
Rate of freedom from target lesion revascularization (TLR) at one year 
Secondary 
Endpoints: 
 
 
 
 Procedural success (≤30% residual stenosis) 
 Procedural safety (freedom from significant embolization (sequelae), or 
dissection) 
 Freedom from major amputation at 30d, 6mo & 12mo 
 Freedom from death at 30d, 6mo & 12mo 
 Freedom from TLR 6 months  
 Patency at 12 months (up to 20 patients) 
Study 
Population: 
The intended population will consist of all patients undergoing endovascular 
treatment of femoropopliteal de novo/restenotic lesions and in-stent restenosis 
with Turbo Power + DCB treatment. 
Design: 
This is a retrospective, single-site, non-randomized study.   
Sample Size: 
Up to 120 patients will be enrolled at Cardiovascular Institute of the South  
Treatment  
 
De novo, restenotic or in-stent restenosis lesions treated with Turbo Power 
Laser atherectomy + Drug-coated balloon angioplasty 
Inclusion 
criteria: 
All patients from Cardiovascular Institute of the South who were treated for 
femoropopliteal de novo/restenotic lesions or in-stent restenosis using Turbo 
Power laser atherectomy plus drug coated balloon angioplasty between 2016-
2017. 
Exclusion 
criteria: 
Any incomplete data on procedural approach and treatment. 
Duration: 
Review of patient data and inclusion into the study is expected to take up to 6 
months. Patient data will be included through 12 months post-procedure.  
Study start: 
Upon receipt of all appropriate approvals and a fully executed contract with 
the site prior to that site enrolling. 
 
 
 

 
 
 
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1. BACKGROUND INFORMATION 
 
Peripheral artery disease (PAD) is a condition where arteries become narrowed due to plaque and 
thrombus buildup and this reduces blood flow to the limbs. Millions of Americans are affected 
by PAD and many more may be asymptomatic. Individuals with PAD have an increased risk for 
heart disease, aortic aneurysms, stroke and an increased mortality. Due to the prevalence of PAD 
in society, research is ongoing to help treat this disease. 1, 2  
 
Percutaneous transluminal angioplasty (PTA) has been one of the most widely used methods of 
treating PAD; however, it is well know that complications and patency rates are disappointing. 
Many studies have suggested combining PTA with a debulking therapy could provide better 
results so there is less tissue compressed. There are many atherectomy devices on the market, but 
to our knowledge, there is a need to determine the optimal algorithm to best treat PAD.3   
 
Excimer laser ablation (ELA) has been performed since 1994 when the first devices received CE 
mark. There are many devices that modify or remove obstructions in the arteries, but the 
Excimer laser is unique as it ablates or vaporizes tissue at the catheter tip. The catheter contains 
optical fibers that transmit pulses of ultraviolet light at 308nm that break down blockages at the 
molecular level. The laser catheters ablate lesions consisting of plaque, thrombus, neointimal 
hyperplasia, and calcium. 
  
The Laser Angioplasty for Critical Ischemia (LACI) Registry used excimer laser catheters 
ranging from 0.9 to 2.5 mm to debulk infrainguinal arteries followed by balloon angioplasty and 
optional stenting. From visual assessment, baseline lesion stenosis was 92% ± 12% and after 
laser use, this decreased to 55% ±24% (p<0.001). 88% of lesions were located in the 
femoropopliteal arteries4. 
 
The CELLO Registry used excimer laser catheters to enlarge the lumen of the superficial femoral 
artery or proximal popliteal. A 2.0mm Turbo-Elite laser catheter was used to create a pilot 
channel and the Turbo Booster laser catheter was utilized to increase the lumen diameter. The 
primary effectiveness endpoint for this study was a decrease of 20% or greater after all laser by 
core lab assessment.  During the study the diameter stenosis was reduced from 77% ± 15% at 
baseline to 34.7% ± 17.8% post all laser5.  
 
The EXCITE Study used Turbo-Elite catheters to create a 2.0 mm pilot channel for Turbo 
Tandem in femoropopliteal in-stent restenosis (ISR) lesions. Operators could use the Turbo-Elite 
for multiple passes and enlarging the lumen, but Turbo Tandem was the device used to conduct 
maximal debulking. This study was randomized to compare ELA + PTA to PTA only with the 
final mean diameter stenosis by visual assessment at 11.5% vs 18.1% respectively (p=0.004)6. 
The protocol was amended during the study to collect visual assessment data post Turbo-Elite. In 
94 patients, Turbo-Elite effectively reduced baseline stenosis from 88.3% ± 12.2% to 49.2% ± 
24.8% with an average mean reduction of 39.1% ± 24.1%. In a post hoc core lab analysis, the 
baseline stenosis of 84.8% ± 14.7% was reduced to 58.1% ± 13.5% with an average mean 
reduction of 26.8% ± 14.3%.  
 

 
 
 
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While studies have shown the decrease in stenosis with excimer laser atherectomy in a variety of 
lesion morphologies and arteries, there are no studies specific to Turbo Power laser atherectomy 
plus drug coated balloon in a variety of lesion morphologies. 
 
2. OBJECTIVE(S) 
 
The objective of this study is to determine outcomes of combined Turbo Power laser 
atherectomy plus drug coated balloon angioplasty for the treatment of femoropopliteal de 
novo/restenotic lesions and in-stent restenosis (ISR). Better understanding of these outcomes will 
help guide optimal treatment algorithms for this difficult to treat cohort of patients. 
 
3. DESIGN 
 
This is a retrospective, single-site, non-randomized study. Up to 120 subjects will be included in 
this study at Cardiovascular Institute of the South. Patient data will be reviewed through 12 
months post-procedure. Out of the 120 patients, up to 20 patients will be included for a sub-
analysis of patency. These 20 patients must be compliant with physician discharge instructions to 
be included in this cohort.  
 
Primary Endpoint: 
Rate of freedom from target lesion revascularization (TLR) at one year 
 
Secondary Endpoints: 
The secondary endpoints consist of:  
 Procedural success (≤30% residual stenosis) 
 Procedural safety (freedom from significant embolization (sequelae), or dissection) 
 Freedom from major amputation at 30d, 6mo & 12mo 
 Freedom from death at 30d, 6mo & 12mo 
 Freedom from TLR 6 months  
 Patency at 12 months (up to 20 patients) 
 
The device involved in this study is the Spectranetics’ Turbo Power laser catheter followed by 
drug coated balloon angioplasty. These devices are currently available in the United States. The 
Turbo Power laser catheter is currently indicated for the treatment of peripheral arterial disease 
including treatment of in-stent restenosis (ISR). Additionally, the two drug-coated balloons on 
the market in the United States during this retrospective timeframe were IN.PACT Admiral 
(Medtronic) and Lutonix 035 (CR Bard). They are both indicated for treatment of peripheral 
arterial disease and specifically, IN.PACT Admiral is indicated for ISR treatment. The present 
protocol does not involve invasive investigational interventions. 
 
4. SELECTION OF SUBJECTS 
4.1 
Study Population 
 
Patients will be recruited from the investigator’s general patient population, and they must meet 
all of the inclusion/exclusion criteria listed below. 
 

 
 
 
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4.2 
Inclusion criteria 
 
All patients from Cardiovascular Institute of the South who were treated for femoropopliteal de 
novo/restenotic lesions or in-stent restenosis using Turbo Power laser atherectomy plus drug 
coated balloon angioplasty during 2016-2017. 
 
4.3 
Exclusion criteria 
Patients will be excluded if there is any incomplete data on procedural approach and 
treatment.  
Discontinuation of Subject Enrollment 
Whenever possible, every subject should remain in the study until the completion of all 
data collection is complete.  However, a subject’s participation may be discontinued at 
any time during the study.  The rationale for discontinuation must be documented in the 
source documentation and in the data collection form. 
 
Factors leading to discontinuation may include: 
 Subject Withdrawal- A subject that has been consented prior to this amendment, 
may withdraw consent at any time for any reason or no reason at all.  Withdrawal 
should not affect the subject’s relationship with the physician, and no penalty or 
loss of benefits (if any) should occur. Every effort should be made by the research 
study staff to obtain the reason for the withdrawal of consent.  
 Investigator Termination- An investigator may discontinue a subject in a study 
due to a significant adverse event or due to failure to cooperate with study 
requirements. 
 Lost-To-Follow-Up- Lost to follow-up is defined as the inability to obtain a 
response from the subject on three separate days.  These contacts may be 
telephone calls or emails to subject (or subject representative and/or primary care 
provider if subject unable to be contacted); however at least one effort should be a 
certified letter to the subject’s last known address. 
 
 
4.4 
Treatment Group 
 
Treatment was performed at the physician’s discretion. The subjects included in this 
retrospective study were treated with Turbo Power laser atherectomy as well as drug-coated 
balloon angioplasty. 
 
               
5. SAMPLE SIZE AND STATISTICAL CONSIDERATIONS 
5.1 
The study is designed to include up to 120 patients. Descriptive statistics (arithmetic 
mean, median as indicated, minimum and maximum and standard deviation) will be 
calculated for continuous variables. Absolute frequencies and percentages will be 
obtained for qualitative variables. 95% Confidence intervals will be provided.  In 

 
 
 
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calculation of percentages, patients with missing data will not be considered, unless 
otherwise specified.  All baseline characteristics will be summarized. Descriptive 
statistics will be used to summarize the values and changes from baseline across time. 
 
6. PROCEDURES 
 
6.1 
Data Review  
All patients from Cardiovascular Institute of the South who were treated for femoropopliteal de 
novo/restenotic lesions or in-stent restenosis using Turbo Power laser atherectomy plus drug 
coated balloon angioplasty between 2016-2017 will be considered for study enrollment.   
 
A review of the study candidate’s medical history, procedure and data 12-months post-procedure 
will be performed and documented on the study CRFs.  
 
Up to 20 patients that have been compliant with the physician’s discharge instructions will be 
included in a subgroup. This subgroup will be specifically reviewed for long-term patency by the 
duplex ultrasound core lab. These patients will have a duplex ultrasound conducted within 305-
425 days post-procedure (±60 days of 12-months post-procedure).  
 
6.2 
Angiographic Core Lab 
An angiographic core lab will be employed to review procedural angiography on the 120 
patients. They will assess baseline lesion characteristics and post-procedural diameter stenosis.  
 
6.3 
Duplex Ultrasound Core Lab 
In the 20 patient subgroup, restenosis of the target lesion will be assessed by the duplex 
ultrasound core lab. These patients will have a duplex ultrasound conducted within 305-425 days 
post-procedure (±60 days of 12-months post-procedure). This will provide long-term patency 
data in these 20 patients. 
 
 
 
7. ETHICAL PROCEDURES 
 
7.1 
Declaration of Helsinki 
 
This study will be conducted according to the US FDA standards of Good Clinical Practice 
(FDA Title 21 Code of Federal Regulations part 11, 50, 54, 56 and 812), the Declaration of 
Helsinki, and the ICH Guidelines. 
7.2 
Patient informed consent 
We are requesting a waiver of consent from IRB as this is a retrospective review and the data 
already exists. The patient’s personal identifying information will not be compromised or 
disclosed. 
Data from patients that have previously declined consent will not be included in the study.     
 
7.3 
Institutional Review Board (IRB) 
The study may not be started at the proposed medical institution until all required approvals for 
the study have been obtained. 

 
 
 
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7.4 
Deviations from the Investigational Plan 
An Investigator is required to conduct this study in accordance with this investigational protocol, 
applicable laws and regulations, and any conditions of approval imposed by the Ethics 
Committees.   
 
 
An Investigator shall notify the reviewing Ethics Committee of any deviation from the 
investigational plan to protect the life or physical well being of a patient in an emergency.  
Such notices shall be given as soon as possible, but no later than 3 working days after the 
emergency has occurred.   
 
Except in such an emergency, prior approval by the Ethics Committee is required for a 
change in or deviation from the plan that could affect the scientific soundness of the plan, 
or the rights, safety or welfare of the patients.  
 
8. DATA COLLECTION AND MANAGEMENT 
 
8.1 
Required Data 
For the duration of the study, the Investigator and their delegates will maintain complete 
and accurate documentation, including but not limited to, medical records, study progress 
notes, signed subject informed consent forms (if applicable), correspondence with the 
reviewing IRB, correspondence with the Sponsor’s designee and Study Monitor, adverse 
event reports, and information regarding subject discontinuation or completion of the 
study. 
 
 
8.2 
Missing Values and Sensitivity Analysis 
Every attempt will be made to obtain missing values.  Missing values will be queried and 
reconciled where possible.  In the event missing values are unable to be resolved, 
sensitivity analyses will be conducted and compared using various scenarios.   
 
8.3 
Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  Those regulations require a signed subject authorization informing the subject 
of the following:  
 What protected health information (PHI) will be collected from subjects in 
this study 
 Who will have access to that information  
 Who will use or disclose that information 
 The rights of a research subject to revoke their authorization for use of their 
PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of 

 
 
 
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subject authorization.  For subjects that have revoked authorization to collect or use PHI, 
attempts should be made to obtain permission to collect at least vital status (i.e. that the 
subject is alive) at the end of their scheduled study period. 
 
All data and information collected during this study will be considered confidential by 
the.  All data used in the analysis and summary of this study will be anonymous, and 
without reference to specific subject names.  Access to subject files will be limited to 
authorized personnel of the Investigator, Clinical Site research staff and authorized 
Regulatory Authorities.  Authorized regulatory personnel have the right to inspect and 
copy all records pertinent to this study 
 
8.4 
Source Documents 
Source data is all information, original records of clinical findings, observations, or other 
activities in a clinical trial necessary for the reconstruction and evaluation of the trial.  
Examples of these original documents, and data records include but are not limited to: 
hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries 
or evaluation checklists, recorded data from automated instruments, copies or 
transcriptions certified after verification as being accurate and complete, microfiches, 
photographic negatives, microfilm or magnetic media, x-rays, subject files, and records 
kept at the pharmacy, at the laboratories, and at core laboratories involved in the clinical 
trial. 
 
Regulations require that the Investigator maintain information in the subject’s medical 
records that corroborate data collected for the study.   
 
8.5 
Case Report Forms 
This study will use a paper case report form (CRF) as the primary data collection 
instrument and data will be entered into an electronic database at the sponsor site.  All 
data requested on the CRF should be entered or if missing, explained.  If any entry error 
has been made, correct and enter the correct data in the CRF.  
 
8.6 
Record Retention 
The Investigator will retain study essential documents for at least two years after 
completion of the trial. 
 
 
 
9. Abbreviations/Definitions 
 
Acute Procedural Success: Defined as  a ≤30% residual stenosis in the target lesion 
immediately post assigned treatment. This assessment will be correlated with the  ACL 
finding. 
 

 
 
 
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Claudication:  Poor circulation and blockage of blood in the leg arteries produces an aching, 
tired, cramping and sometimes burning pain in the hips, thighs, or calves when the leg 
muscles do not receive the oxygen rich blood required during exercise or at rest. 
 
Dissection:  A separation of the vessel structures or formation of a false lumen. Flow-limiting 
dissection is considered Grade D or greater. 
 
GRADE DISSECTION DESCRIPTION 
A 
Small radiolucent area within the lumen of the vessel disappearing with the 
passage of the contrast material. 
 
B 
Filling defect parallel to the lumen of the vessel disappearing with the 
passage of contrast material. 
 
C 
Dissection protruding outside the lumen of the vessel persisting after 
passage of contrast material. 
 
D 
Spiral shaped filling defect with delayed runoff of the contrast material in 
the distal vessel. 
 
E 
Persistent luminal filling defect with delayed anterograde flow  
 
F 
Filling defect accompanied by total occlusion 
 
 
 
Distal Embolization: Free-flowing blood clot or lesion material located distal from the treated 
lesion.  Significant distal embolization: In event of clinical sequelae, treatment was needed to 
remove emboli. 
 
Major Amputation: Unplanned amputation of the target limb where prosthesis is required for 
standing or walking.  
 
Occlusion:  No flow identified within the arterial segment by ultrasound and/or angiogram. 
 
Patency:  Loss of patency will be determined by duplex ultrasound (DUS). DUS analysis will be 
performed per core lab protocol 
 
Percent Stenosis:  Native vessel diameter as measured at the most narrow point of the lesion 
divided by the estimated native vessel diameter at that location using angiographic images 
with visual estimate. 
 
P1 Segment of the Popliteal Artery: the first portion of the popliteal artery between the Hunter 
canal and the popliteal fossa. 
 
P2 Segment of the Popliteal Artery: from the popliteal fossa to the knee joint 

 
 
 
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P3 Segment of the Popliteal Artery: from the knee joint to the take-off of the anterior tibial 
artery 
 
Provisional Procedures: Additional devices used at time of procedure that exclude Turbo 
Power laser atherectomy and drug-coated balloon.  
 
Rutherford Categories: 
 
 
Category 
Clinical Criteria 
0 
Asymptomatic – No 
hemodynamically significant 
occlusive disease; Mild 
claudication 
1 
Mild Claudication 
2 
Moderate Claudication 
3 
Severe Claudication 
4 
Ischemic Rest Pain 
5 
Minor tissue loss – Non-healing 
ulcer; Focal gangrene with 
diffuse pedal ischemia 
6 
Major tissue loss – Extending 
transmetatarsally; functional 
appendage/limb no longer 
salvageable 
 
 
 
Target Lesion Revascularization (TLR): A Target Lesion Revascularization is defined as any 
percutaneous or surgical intervention to treat a restenosis or reocclusion, in the target lesion. 
 
Target Vessel Revascularization (TVR): Any percutaneous or surgical intervention to treat a 
restenosis or reocclusion within the target vessel. 

 
 
 
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9. REFERENCES 
1. Tunis SR, Bass EB, Steinberg EP; Use of angioplasty, bypass surgery, and amputation in the 
management of peripheral vascular disease. New Eng J Med 1991;325:556-562 
2. U.S. Bureau of Census. Current Population Reports, Special Studies, 65+ in the United 
States. U.S. Government Printing Office, Washington DC, 1996 
3. Taylor LM and Porter JM; Natural history and nonoperative treatment of chronic lower 
extremity ischemia in  Vascular Surgery, RB Rutherford ed., WB Saunders; Philadelphia, 
1989:653-667 
4. Rose GA; The diagnosis of ischemic heart pain and intermittent claudication in field surveys. 
Bulletin of the World Health Organization. 1962; 654-658 
5. Whittemore A D; Autogenous saphenous vein versus PTFE bypass for above-knee 
femoropopliteal reconstruction. J Vasc Surg 1992; 15:895-897  
6. Kram H B, Gupta S K, Veith F J; Late results of two hundred seventeen femoropopliteal 
bypasses to isolated popliteal artery segments. J Vasc Surg 1991; 14:386-390 
7. Veith FJ, Gupta SK, Ascer E, White-Flores S, et al; Six-year prospective multicenter 
randomized comparison of autologous saphenous vein and expanded polytetrafluorethylene 
grafts of infrainguinal arterial reconstructions. J Vasc Surg 1986; 3:104-114 
8. Wilson S E, Wolf G L, Cross A P; Percutaneous transluminal angioplasty versus operation 
for peripheral arteriosclerosis; J Vasc Surg 1989; 9:1-9  
9. Murray R, Hewes R C, White R I; Long-segment femoropopliteal stenoses:  is angioplasty a 
boon or a bust? Radiology 1987; 162:473-476  
10. Salem H K T, Gussenhoven E J, Zhong Y, Li W, van Egmond, et al; Effect of balloon 
angioplasty on femoral artery evaluated with intravascular ultrasound imaging. Circulation 
1992; 86:483-493  
11. Visona A, Perissinotto C, Lusiana L et al.  Percutaneous excimer laser angioplasty of lower 
limb vessels:  results of a prospective 24-month follow-up.  Angiology 1998; 49:91-98 
12. Dalsing MC, Cockerill E, Deupree R, et al.; Outcome predictors of balloon angioplasty of 
surgery for peripheral arterial occlusive disease. Surgery 1991; 110:634-644 
13. Cho L,  Roffi M, Mukherjee D, Bhatt DL, Bajzer C, Yadav JS.  Superficial Femoral Artery 
Occlusion: Nitinol Stents Achieve Flow and Reduce the Need for Medications Better than 
Balloon Angioplasty Alone.  J Invasive Cardiol 15(4):198-200, 2003.   
14. Rocha-Singh, K J, Jaff, M R, Crabtree, T R, Bloch, D A, Ansel, G. Performance Goals and 
Endpoint Assessments for Clinical Trials of Femoropopliteal Bare Nitinol Stents in Patients 
with Symptomatic Peripheral Arterial Disease. Catherterization and Cardiovascular 
Interventions 69:910-919 (2007). 
15. Diehm N, Baumgartner I, Jaff M, Do DD, Minar E, Schmidli J, Diehm C, Biamino G, 
Vermassen F, Scheinert D, van Sambeek MRHM, Schillinger M.  A call for uniform 
reporting standards in studies assessing endovascular treatment for chronic ischaemia of 
lower limb arteries.  Eu Heart J.  2007; 28: 798-805. 
16. Schlager O, Francesconi M, Haumer M, Dick R, Sabeti S, Amighi J, Mlekusch W, 
Koppensteiner R, minar E, Schillinger M.  Duplex sonography versus arteriography for 
assessment of femoropopliteal artery disease in a “real-world” setting.  J Endovasc Ther. 
2007; 14: 452-459. 
17. Gerhard-Herman M, Gardin JM, Jaff M, Mohler E, Roman M, Naqvi TZ.  Guidelines for 
noninvasive vascular laboratory testing: A report from the American Society of 

 
 
 
Page 12 of 12 
Walker TurboPower+DCB Retro 
20Mar2018 
Echocardiography and the Society of Vascular Medicine and Biology.  J Am Soc 
Echocardiogr. 2006; 19: 955-972.    
18. Ranke C, Creutzig A, Alexander K.  Duplex scanning of the peripheral arteries: correlation 
of peak velocity ratio with angiographic diameter reduction.  Ultrasound Med Biol.  1992; 
18(5): 433-40. 
19. Scheinert D,  Laird Jr JR, Schroder M, Steinkamp H, Balzer JO, Biamino G.  Excimer laser-
assisted recanalization of long, chronic superficial femoral artery occlusions. J Endovasc 
Ther. 2001;8:156–166. 
20. Norgren L, Hiatt WR, Dormandy JA, Nehler MR Harris KA, Fowkes FGR for the TASC II 
Working Group.  Inter-Society Consensus for the Management of Peripheral Arterial 
Disease (TASC II).  J Vasc Surg.  2007: 45: Sup S 5-S67A.