search
Back to results

The Chocolate Touch Study

Primary Purpose

Intermittent Claudication, Ischemia

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Chocolate Touch
Lutonix Drug Coated Balloon
Sponsored by
TriReme Medical, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Minimum of 18 years of age
  2. Intermittent claudication or ischemic rest pain (Rutherford 2-4)
  3. Life Expectancy >2 years
  4. Patient has agreed to follow-up requirements and given informed consent
  5. Lesion successfully crossed with a guidewire
  6. Lesion in the superficial femoral or popliteal artery
  7. Target lesion >70% stenosis
  8. Reference Vessel Diameter between 3.5 & 6.0mm and within treatment range of Chocolate Touch to be used 1.1:1 at Target Lesion
  9. Target Lesion <18cm that consists of no more than two adjacent lesions (<25mm apart) and is able to be completely covered with inflation of no more than two assigned balloons
  10. Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant (>70%) stenosis from origin to to ankle
  11. In-flow vessel without significant stenosis (<70%) or successful treatment (<30% residual stenosis with no complications) of a diseased iliac vessel

Exclusion Criteria:

  1. Acute limb ischemia, or patient indicated for thrombolytic therapy
  2. Planned surgery within 30 days including interventions on the non-target limb
  3. Target Limb concurrent interventions involving a re-entry device, atherectomy, laser, or ablation procedures, the use of a drug eluting stent, or, treatment with any other drug coated balloon
  4. Myocardial infarction or stroke within 30 days prior to the procedure
  5. Known intolerance to required medications, contrast media, nitinol, or Paclitaxel
  6. Known impaired Renal Function that could have an impact on contrast tolerance with Glomerular filtration rate (GFR) ≤ 30 ml/min per 1.73 m^2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L)
  7. Known bleeding disorder or uncontrolled hypercoagulable disorder
  8. Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease)
  9. Female who is pregnant or intends to be pregnant during study
  10. Patient is enrolled in another clinical study or was previously enrolled in this study
  11. Presence of perforation, dissection or other injury at access site or in target vessel at time of enrollment
  12. Severe Calcification at the target lesion (defined as angiographic evidence of dense calcification present on both sides of the vessel wall on two orthogonal views and that extends >5 continuous cm in length)
  13. Previous bypass graft or stent at target vessel, OR, iliac stent that cannot permit crossing by the treatment balloon within the introducer sheath

Sites / Locations

  • Cardiac and Vascular Institute
  • Mt. Sinai - Miami
  • Emory University
  • Alexian Brothers
  • Cardiovascular Institute of the South
  • Michigan Outpaitient Vascular Institution
  • Mid-Michigan Heart & Vascular
  • Jackson Heart
  • St. Luke's Hospital
  • Deborah Heart
  • Mt. Sinai Heart
  • Columbia University Medical Center / NewYork Presbyterian Hospital
  • Univeristy Hospitals Cleveland Medical Center
  • Holy Spirit Cardiovascular Institute
  • Pinnacle Health Cardiovascular Institute
  • Lankenau Medical Center
  • Wellmont CVA Heart Institute
  • Hurricane Cardiology
  • MIssion Research
  • Swedish Medical Center
  • LKH Univ. Klinikum Graz
  • Medical University of Graz
  • Angiologie - Hansuchkrankenhaus
  • Universitat Herz-Zentrum
  • Leipzig University
  • Auckland City Hospital
  • Waikato Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Group (Chocolate Touch)

Control Group (Lutonix Drug Coated Balloon)

Arm Description

The diameter of the Chocolate Touch should correspond to the diameter of the vessel for treatment with a balloon to artery ratio of 1.1:1. The Chocolate Touch must be inflated to at least nominal pressure. Maintain balloon inflation for a minimum of 2 minutes. The balloon may be inflated as long as required to achieve optimal angioplasty outcome. If delivery is attempted and failed, a new Chocolate Touch should be used for subsequent attempts after pre-dilatation.

Never inflate the Lutonix® Drug Coated Balloon (DCB)prior to reaching the target lesion. The Lutonix® Catheter should be advanced to the target site as fast as possible (i.e. 30 seconds) and immediately inflated to appropriate pressure to ensure full wall apposition (balloon to artery ratio of >1:1). If the deployment of the Lutonix® Catheter exceeds 3 minutes, the catheter requires placement with a new unit. Maintain balloon inflation for a minimum of 2 minutes (120 seconds). The balloon may be inflated as long as required by standard of care to achieve a good angioplasty outcome.

Outcomes

Primary Outcome Measures

True Drug Coated Balloon Success
A composite endpoint that requires patients to achieve Primary Patency (Peak systolic velocity ratio <2.4 without the need for clinically driven target lesion revascularization) in the absence of a clinically driven bail-out stent (core lab adjudicated).
Freedom from Major Adverse Events
Composite of target-limb-related death, major amputation of the target limb, and clinically driven re-intervention of the target limb.

Secondary Outcome Measures

By Angiographic Core Lab Review (Acute)
Procedural Success: Defined as the success of the therapy to achieve <30% diameter stenosis without a flow-limiting dissection or the need for a stent
By Duplex Ultrasound Core Lab Review
Patency
By Clinical Assessment
Occurrence of relevant Adverse Events

Full Information

First Posted
October 3, 2016
Last Updated
December 21, 2020
Sponsor
TriReme Medical, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT02924857
Brief Title
The Chocolate Touch Study
Official Title
A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch™ Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriReme Medical, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Chocolate Touch study is a randomized, multi-center, prospective, adaptive study, designed to show sufficient safety and effectiveness of the Chocolate Touch™ for use in superficial femoral or popliteal arteries with the intention of obtaining regulatory approval to market this device in the United States
Detailed Description
The primary objective of the Chocolate Touch study is to demonstrate non-inferior safety and non-inferior effectiveness of the Chocolate Touch™ compared to the Lutonix® drug coated balloon catheter. These data are intended to show safety and effectiveness of the Chocolate Touch sufficient to support regulatory approval to market this device in the United States for use in superficial femoral or popliteal arteries. Study success is defined as statistical demonstration of the non-inferiority hypothesis tests for both the primary safety and effectiveness hypothesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication, Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
585 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Group (Chocolate Touch)
Arm Type
Experimental
Arm Description
The diameter of the Chocolate Touch should correspond to the diameter of the vessel for treatment with a balloon to artery ratio of 1.1:1. The Chocolate Touch must be inflated to at least nominal pressure. Maintain balloon inflation for a minimum of 2 minutes. The balloon may be inflated as long as required to achieve optimal angioplasty outcome. If delivery is attempted and failed, a new Chocolate Touch should be used for subsequent attempts after pre-dilatation.
Arm Title
Control Group (Lutonix Drug Coated Balloon)
Arm Type
Active Comparator
Arm Description
Never inflate the Lutonix® Drug Coated Balloon (DCB)prior to reaching the target lesion. The Lutonix® Catheter should be advanced to the target site as fast as possible (i.e. 30 seconds) and immediately inflated to appropriate pressure to ensure full wall apposition (balloon to artery ratio of >1:1). If the deployment of the Lutonix® Catheter exceeds 3 minutes, the catheter requires placement with a new unit. Maintain balloon inflation for a minimum of 2 minutes (120 seconds). The balloon may be inflated as long as required by standard of care to achieve a good angioplasty outcome.
Intervention Type
Device
Intervention Name(s)
Chocolate Touch
Other Intervention Name(s)
Chocolate Touch™ Paclitaxel Coated Balloon Catheter
Intervention Description
The Chocolate Touch™ Paclitaxel Coated Balloon Catheter is indicated for balloon dilatation, after appropriate vessel preparation as needed, of lesions in native superficial femoral or popliteal arteries up to 18 cm in length that are appropriate for angioplasty with balloon diameters from 3.5 mm to 6.0mm.
Intervention Type
Device
Intervention Name(s)
Lutonix Drug Coated Balloon
Other Intervention Name(s)
LUTONIX® 035 Drug Coated Balloon Catheter
Intervention Description
The Lutonix® 035 Drug Coated Balloon Catheter is indicated for improving luminal diameter for the treatment of obstructive de novo or non-stented restenotic lesions (≤ 18 cm in length) in native femoropopliteal arteries having reference vessel diameters of 4 mm to 6 mm.
Primary Outcome Measure Information:
Title
True Drug Coated Balloon Success
Description
A composite endpoint that requires patients to achieve Primary Patency (Peak systolic velocity ratio <2.4 without the need for clinically driven target lesion revascularization) in the absence of a clinically driven bail-out stent (core lab adjudicated).
Time Frame
12 months
Title
Freedom from Major Adverse Events
Description
Composite of target-limb-related death, major amputation of the target limb, and clinically driven re-intervention of the target limb.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
By Angiographic Core Lab Review (Acute)
Description
Procedural Success: Defined as the success of the therapy to achieve <30% diameter stenosis without a flow-limiting dissection or the need for a stent
Time Frame
1 hour
Title
By Duplex Ultrasound Core Lab Review
Description
Patency
Time Frame
6, 12 & 24 months
Title
By Clinical Assessment
Description
Occurrence of relevant Adverse Events
Time Frame
1, 6, 12, & 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Minimum of 18 years of age Intermittent claudication or ischemic rest pain (Rutherford 2-4) Life Expectancy >2 years Patient has agreed to follow-up requirements and given informed consent Lesion successfully crossed with a guidewire Lesion in the superficial femoral or popliteal artery Target lesion >70% stenosis Reference Vessel Diameter between 3.5 & 6.0mm and within treatment range of Chocolate Touch to be used 1.1:1 at Target Lesion Target Lesion <18cm that consists of no more than two adjacent lesions (<25mm apart) and is able to be completely covered with inflation of no more than two assigned balloons Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant (>70%) stenosis from origin to to ankle In-flow vessel without significant stenosis (<70%) or successful treatment (<30% residual stenosis with no complications) of a diseased iliac vessel Exclusion Criteria: Acute limb ischemia, or patient indicated for thrombolytic therapy Planned surgery within 30 days including interventions on the non-target limb Target Limb concurrent interventions involving a re-entry device, atherectomy, laser, or ablation procedures, the use of a drug eluting stent, or, treatment with any other drug coated balloon Myocardial infarction or stroke within 30 days prior to the procedure Known intolerance to required medications, contrast media, nitinol, or Paclitaxel Known impaired Renal Function that could have an impact on contrast tolerance with Glomerular filtration rate (GFR) ≤ 30 ml/min per 1.73 m^2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L) Known bleeding disorder or uncontrolled hypercoagulable disorder Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease) Female who is pregnant or intends to be pregnant during study Patient is enrolled in another clinical study or was previously enrolled in this study Presence of perforation, dissection or other injury at access site or in target vessel at time of enrollment Severe Calcification at the target lesion (defined as angiographic evidence of dense calcification present on both sides of the vessel wall on two orthogonal views and that extends >5 continuous cm in length) Previous bypass graft or stent at target vessel, OR, iliac stent that cannot permit crossing by the treatment balloon within the introducer sheath
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehdi Shishehbor, DO
Organizational Affiliation
Cleveland Medical Center, Cleveland, Ohio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Zeller, MD
Organizational Affiliation
Universitat Herzzentrum, Bad Krozingen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiac and Vascular Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Mt. Sinai - Miami
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Alexian Brothers
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Michigan Outpaitient Vascular Institution
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
Mid-Michigan Heart & Vascular
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Jackson Heart
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Deborah Heart
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Mt. Sinai Heart
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center / NewYork Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Univeristy Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Holy Spirit Cardiovascular Institute
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Pinnacle Health Cardiovascular Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Wellmont CVA Heart Institute
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Hurricane Cardiology
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
MIssion Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
LKH Univ. Klinikum Graz
City
Graz
ZIP/Postal Code
A-0836
Country
Austria
Facility Name
Medical University of Graz
City
Graz
Country
Austria
Facility Name
Angiologie - Hansuchkrankenhaus
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Universitat Herz-Zentrum
City
Bad Krozingen
Country
Germany
Facility Name
Leipzig University
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3210
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15262830
Citation
Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation. 2004 Aug 10;110(6):738-43. doi: 10.1161/01.CIR.0000137913.26087.F0. Epub 2004 Jul 19.
Results Reference
background
PubMed Identifier
11560536
Citation
Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. doi: 10.1001/jama.286.11.1317.
Results Reference
background
PubMed Identifier
17140820
Citation
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
Results Reference
background
PubMed Identifier
16549646
Citation
Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.
Results Reference
background
PubMed Identifier
17101615
Citation
Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.
Results Reference
background
PubMed Identifier
18272892
Citation
Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.
Results Reference
background
PubMed Identifier
18779447
Citation
Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8. Erratum In: Circulation. 2008 Oct 14;118(16):e670.
Results Reference
background
PubMed Identifier
24456716
Citation
Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G, Naisbitt S, Rosenfield K. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014 Jan;7(1):10-9. doi: 10.1016/j.jcin.2013.05.022.
Results Reference
background
PubMed Identifier
21884945
Citation
Schmidt A, Piorkowski M, Werner M, Ulrich M, Bausback Y, Braunlich S, Ick H, Schuster J, Botsios S, Kruse HJ, Varcoe RL, Scheinert D. First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome. J Am Coll Cardiol. 2011 Sep 6;58(11):1105-9. doi: 10.1016/j.jacc.2011.05.034.
Results Reference
background
PubMed Identifier
23192918
Citation
Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, Eschenbach G, Hartmann H, Lange C, Schnorr B, Stiepani H, Zoccai GB, Hanninen EL. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012 Dec;5(6):831-40. doi: 10.1161/CIRCINTERVENTIONS.112.971630. Epub 2012 Nov 27.
Results Reference
background
PubMed Identifier
20948503
Citation
Schnorr B, Kelsch B, Cremers B, Clever YP, Speck U, Scheller B. Paclitaxel-coated balloons - Survey of preclinical data. Minerva Cardioangiol. 2010 Oct;58(5):567-82.
Results Reference
background
PubMed Identifier
21983304
Citation
Schnorr B, Speck U, Scheller B. Review of clinical data with Paccocath- coated balloon catheters. Minerva Cardioangiol. 2011 Oct;59(5):431-45.
Results Reference
background
PubMed Identifier
21460774
Citation
Zeller T, Schmitmeier S, Tepe G, Rastan A. Drug-coated balloons in the lower limb. J Cardiovasc Surg (Torino). 2011 Apr;52(2):235-43.
Results Reference
background
PubMed Identifier
8580930
Citation
Morikawa T, Yoshida M. A useful testing strategy in phase III trials: combined test of superiority and test of equivalence. J Biopharm Stat. 1995 Nov;5(3):297-306. doi: 10.1080/10543409508835115.
Results Reference
background
PubMed Identifier
35377157
Citation
Shishehbor MH, Zeller T, Werner M, Brodmann M, Parise H, Holden A, Lichtenberg M, Parikh SA, Kashyap VS, Pietras C, Tirziu D, Ardakani S, Beschorner U, Krishnan P, Niazi KA, Wali AU, Lansky AJ. Randomized Trial of Chocolate Touch Compared With Lutonix Drug-Coated Balloon in Femoropopliteal Lesions (Chocolate Touch Study). Circulation. 2022 May 31;145(22):1645-1654. doi: 10.1161/CIRCULATIONAHA.122.059646. Epub 2022 Apr 4.
Results Reference
derived

Learn more about this trial

The Chocolate Touch Study

We'll reach out to this number within 24 hrs