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What are the Novel Devices and
Technologies in 2014 to Treat Peripheral
Artery Disease

Mehdi H. Shishehbor, DO, MPH, PhD
Director, Endovascular Services
Staff, Interventional cardiology and Vascular Medicine
Cleveland Clinic


Current limitations Associated with
SFA Treatment
• Patency
– Long lesions

• Re-stenosis

• Stent Fracture
– Re-stenosis
– Thrombosis
– Pseudoaneurysm

• Cost
Scheinert D, et al. JACC 2005; 45 (2):312-315


Binary restenosis @ 12 months (%)

Lesion/stent Length and Patency
PTA PLUS PROVISIONAL STENT
PRIMARY STENT

Shillinger,M 2009

ABSOLUTE

ASTRON
RESILIENT
FAST

ABSOLUTE
FAST

ASTRON
RESILIENT

Length of the lesion (cm)


Binary restenosis @ 12 months (%)

Comparison of SFA Trials
PTA ALONE
PTA PLUS PROVISIONAL STENT
PRIMARY STENT
ZILVER
Balloon suboptimal

DES

Shillinger & Baumgartner 2010

ABSOLUTE

ASTRON

RESILENT

RESILIENT
FAST

ZILVER
Balloon optimal
PTA plus stent

ASTRON

FAST
RESILIENT
ZILVER PTX

Length of the lesion (cm)

ABSOLUTE


Binary restenosis @ 12 months (%)

Comparison of SFA Trials
PTA ALONE
PTA PLUS PROVISIONAL STENT

PRIMARY STENT
ZILVER PTX
Balloon suboptimal

DES
VIABAHN

Shillinger & Baumgartner 2010

ABSOLUTE

ASTRON

RESILENT

RESILIENT
FAST

ZILVER
Balloon optimal
PTA plus stent

FAST

ABSOLUTE

MCQUADE
25 CM

ASTRON

KEDORA
25 CM

RESILIENT
ZILVER PTX

FISCHER

Length of the lesion (cm)


Standard Nitinol Stents
(SNS)
Smart (Cordis)

Wire Interwoven
Stents

Covered/Stent
Grafts

SUPERA (Abbott Vascular)

Viabahn (Gore)

Protégé Everflex (eV3)
LifeStent (Bard)
Luminexx (Bard)
Absolute (Abbott)
Xpert (Abbott)

Zilver / PTX (Cook)
Complete SE (Medtronic)
Misago (Terumo)
FlexStent (Flexible Stent Tech)

Fluency (Bard)


Paradigm Shift!
• Angioplasty alone
• Drug coated balloon

• Spot stenting
• TACK-IT technology



Current limitations Associated with
BKA Treatment
• Patency
– Long lesions

• Limited Stent options
– DES

• Data on DEB now ??

• Angioplasty

Currently No DEB are available for
Below Knee Disease!!


Current limitations of DEB
• Acute dissection
• Significant recoil
• Minimal acute luminal gain
• Presence of Ca+


The Chocolate Balloon


How Does Chocolate Balloon
Address These Limitations?
Unique nitinol “constraining structure”
• Shields vessel wall from torsional shear stress
caused by balloon “unfolding”
• Uniformly distributes longitudinal & circumferential
forces
• Modifies plaque via:
 “Pillows”: Vessel dilatation without cutting or
scoring
 “Grooves”: Stress relief, plaque modification


What Does this Mean Clinically?
Bail-Out Stenting Rates

• Fewer dissections

20%

• More aggressive sizing
14%

• Increased acute luminal gain

12%

• Longer term patency

5%

3%

• Less stent utilization

Chocolate
BAR

Schmidt
Bosiers,
BTK DEB PTA Arm

Schmidt Odink, PTA
BTK PTA
Study

Future
• DRUG COATED CHOCOLATE BALLOON!!
(CHOCOLATE TOUCH)
– Address acute issues with the current DEB
technology:
» Dissection
» Recoil
» Acute luminal gain
» Ca+
– Offer long-term patency (paclitaxel)


72 year old male
• 2 prior kidney transplants
• CKD – cr ~ 2.8

• CAD s/p CABG X 2
• Hypertension

• HL
• DM
• Presents with rest pain and multiple ulcer




The ENDURE Chocolate DEB Clinical Trial Design
Up to 5 sites in New Zealand and Europe; Up to 80 patients; Single-Arm Trial
•

•
•
•

Single or Tandem de novo lesion
Total lesion length ≤ 150 mm
RVD 2.0 – 6.0 mm
Rutherford Grade 3-5

Clinical

ATK:

30D

3MO

6MO

12MO

30D

3MO

6MO

12MO

dUS, QVA

Clinical

BTK:
dUS, QVA

•
•
•
•
•

Study Endpoints:
Late Lumen Loss – Angiography (QVA Core Lab)
Patency Rate – Duplex Ultrasound (dUS Core Lab)
TLR Rate
Amputation Free Survival
Rutherford Grade change


Why CTOs are a Problem?
• Time Commitment & skill set
• Failure rate

• More complications
• Cost
• More radiation and contrast
• Poor Patency


Lancet. 2005 Dec 3;366(9501):1925-34.

Over 30% of CTOs Can Not be Crossed
in the Antegrade Approach

Lancet. 2005 Dec 3;366(9501):1925-34
J Endovasc Ther 2008;15:594–604


Manual Rotation/Spining

Mechanical Rotation/Spining

Differential Dissection
Viance

TM

TruePath

Wildcat

TM

TM

TM

Crosser

TM

Frontrunner

Speaker Name

Kittycat 2

TM

Ocelot

TM


Percent Success
Ann Vasc Surg. 2014 Aug;28(6):1439-48.


83 year old female
• Hypertension
• HL

• DM
• CR ~ 1.2
• Presents with rest pain and large ulcer