The Chocolate Touch Study

A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch™ Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions

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

Study Overview

• Status: Active, not recruiting
• Conditions: Ischemia; Intermittent Claudication; Peripheral Artery Disease (PAD)
• Intervention / Treatment: Device: Chocolate Touch; Device: Lutonix Drug Coated Balloon

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.

PMA P210039 approval has been granted on 11/04/2022. The study is now in the post-approval phase.

• Study Type: Interventional
• Enrollment (Actual): 333
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, A-0836
    • Medical University of Graz - LKH Univ.-Klinikum Graz
  • Vienna, Austria, 1140
    • Angiologie - Hansuchkrankenhaus
• Germany
  • Bad Krozingen, Germany
    • Universitat Herz-Zentrum
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital
  • Hamilton, New Zealand, 3210
    • Waikato Hospital
• United States
  • Florida
    • Gainesville, Florida, United States, 32605
      • Cardiac and Vascular Institute
    • Miami Beach, Florida, United States, 33140
      • Mt. Sinai - Miami
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Michigan Outpaitient Vascular Institution
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
  • New York
    • New York, New York, United States, 10029
      • Mt. Sinai Heart
    • New York, New York, United States, 10032
      • Columbia University Medical Center / NewYork Presbyterian Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Univeristy Hospitals Cleveland Medical Center
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Penn State Health Holy Spirit Medical Center
    • Wormleysburg, Pennsylvania, United States, 17043
      • Pinnacle Health Cardiovascular Institute
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
  • Texas
    • New Braunfels, Texas, United States, 78130
      • MIssion Research
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

General:

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

   Angiographic:

5. Lesion successfully crossed with a guidewire
6. Lesion in the SFA or popliteal artery defined as a lesion with a proximal origin >10 mm from SFA origin (deep femoral artery) and a distal end above the knee joint (at least 3 cm above bottom of the femur - P1).
7. Target Lesion ≥70% stenosis in the SFA or popliteal arteries
8. Reference Vessel Diameter (RVD) between 4.0 & 6.0mm and within treatment range of Chocolate Touch to be used 1.1:1 at the Target Lesion
9. Target Lesion ≤180mm 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 (with minimum of >5mm overlap to the area covered by the first balloon). (Note: Adjacent or tandem target lesions must be treated as a single lesion.)
10. Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant (≥70%) stenosis from origin to ankle
11. In-flow vessel without significant stenosis (≥70%) or successful treatment (≤30% residual stenosis with no complications) of a diseased vessel. Note: treatment of contralateral iliac is permissible.

Exclusion Criteria

General:

1. Acute limb ischemia, or patient indicated for thrombolytic therapy
2. Planned surgical or interventional procedures within 30 days after study procedure.
3. Non-target lesion 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 that cannot be adequately premedicated, nitinol, or Paclitaxel
6. Known impaired Renal Function that could have an impact on contrast tolerance with GFR ≤ 30 ml/min per 1.73 m2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L) or on dialysis.
7. Known bleeding disorder, or on dialysis, 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 investigational clinical study or was previously enrolled in this study

    Angiographic:

11. Presence of perforation, dissection (Type D or worse) or other injury 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 >50 continuous mm in length).
13. Previous bypass graft, stent at target vessel (must be greater than 20mm from target lesion), or iliac stent that cannot permit crossing by the treatment balloon within the introducer sheath (Note: In-stent restenosis is not allowed.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group (Chocolate Touch); 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.	Device: Chocolate Touch; 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.; Other Names: Chocolate Touch™ Paclitaxel Coated Balloon Catheter
Active Comparator: Control Group (Lutonix Drug Coated Balloon); 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.	Device: Lutonix Drug Coated Balloon; 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.; Other Names: LUTONIX® 035 Drug Coated Balloon Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 hour
By Duplex Ultrasound Core Lab Review	Patency	6, 12, 24, & 36 months
By Clinical Assessment	Occurrence of relevant Adverse Events	6, 12, 24, & 36 months

Collaborators and Investigators

• Sponsor: TriReme Medical, LLC
• Investigators: Principal Investigator: Mehdi Shishehbor, DO, Cleveland Medical Center, Cleveland, Ohio; Principal Investigator: Thomas Zeller, MD, Universitat Herzzentrum, Bad Krozingen, Germany

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Schnorr B, Speck U, Scheller B. Review of clinical data with Paccocath- coated balloon catheters. Minerva Cardioangiol. 2011 Oct;59(5):431-45.
• 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.
• 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.
• 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.
• 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.
• Bohme T, Zeller T, Shishehbor MH, Werner M, Brodmann M, Parise H, Holden A, Lichtenberg M, Parikh SA, Kashyap VS, Pietras C, Tirziu D, Beschorner U, Krishnan P, Niazi KA, Wali AU, Lansky AJ. Chocolate Touch Versus Lutonix Drug-Coated Balloon for Femoropopliteal Lesions in Diabetes: The Chocolate Touch Study. J Endovasc Ther. 2023 Jun 14:15266028231179589. doi: 10.1177/15266028231179589. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2017
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 3, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimated): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Intermittent Claudication; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: CLP788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes