The Chocolate Touch Study

NCT02924857 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CLP788
• Study Type: interventional
• Target: 333
• Locations: 4 countries
• Sites: 20

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

Conditions

Peripheral Artery Disease (PAD); Ischemia; Intermittent Claudication

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• By Angiographic Core Lab Review (Acute)

  1 hour

• By Duplex Ultrasound Core Lab Review

  6, 12, 24, & 36 months

• By Clinical Assessment

  6, 12, 24, & 36 months

Study Arms (2)

Test Group (Chocolate Touch)

EXPERIMENTAL

* 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

Control Group (Lutonix Drug Coated Balloon)

ACTIVE COMPARATOR

* 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

Interventions

Chocolate Touch DEVICE

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.

Also known as: Chocolate Touch™ Paclitaxel Coated Balloon Catheter

Test Group (Chocolate Touch)

Lutonix Drug Coated Balloon DEVICE

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.

Also known as: LUTONIX® 035 Drug Coated Balloon Catheter

Control Group (Lutonix Drug Coated Balloon)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General:
• 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
• Angiographic:
• Lesion successfully crossed with a guidewire
• 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).
• Target Lesion ≥70% stenosis in the SFA or popliteal arteries
• 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
• 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.)
• Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant (≥70%) stenosis from origin to ankle
• 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.

You may not qualify if:

• General:
• Acute limb ischemia, or patient indicated for thrombolytic therapy
• Planned surgical or interventional procedures within 30 days after study procedure.
• 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.
• Myocardial infarction or stroke within 30 days prior to the procedure
• Known intolerance to required medications, contrast media that cannot be adequately premedicated, nitinol, or Paclitaxel
• 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.
• Known bleeding disorder, or on dialysis, 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 investigational clinical study or was previously enrolled in this study
• Angiographic:
• Presence of perforation, dissection (Type D or worse) or other injury 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 \>50 continuous mm in length).
• 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.)

Sponsors & Collaborators

• TriReme Medical, LLC: lead

Study Sites (20)

Cardiac and Vascular Institute

Gainesville, Florida, 32605, United States

Location

Mt. Sinai - Miami

Miami Beach, Florida, 33140, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Michigan Outpaitient Vascular Institution

Dearborn, Michigan, 48126, United States

Location

Jackson Heart

Jackson, Mississippi, 39216, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Mt. Sinai Heart

New York, New York, 10029, United States

Location

Columbia University Medical Center / NewYork Presbyterian Hospital

New York, New York, 10032, United States

Location

Univeristy Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Penn State Health Holy Spirit Medical Center

Camp Hill, Pennsylvania, 17011, United States

Location

Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, 17043, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

MIssion Research

New Braunfels, Texas, 78130, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Medical University of Graz - LKH Univ.-Klinikum Graz

Graz, A-0836, Austria

Location

Angiologie - Hansuchkrankenhaus

Vienna, 1140, Austria

Location

Universitat Herz-Zentrum

Bad Krozingen, Germany

Location

Auckland City Hospital

Auckland, New Zealand

Location

Waikato Hospital

Hamilton, 3210, New Zealand

Location

Related Publications (16)

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 18272892 BACKGROUND

• 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.

  PMID: 18779447 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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. 2025 Apr;32(2):414-422. doi: 10.1177/15266028231179589. Epub 2023 Jun 14.

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MeSH Terms

Conditions

Peripheral Arterial Disease; Ischemia; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Mehdi Shishehbor, DO

  Cleveland Medical Center, Cleveland, Ohio

  PRINCIPAL INVESTIGATOR

• Thomas Zeller, MD

  Universitat Herzzentrum, Bad Krozingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 5, 2016
• Study Start: July 26, 2017
• Primary Completion: June 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); US (15); NZ (2); DE (1)