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Peripheral Artery Disease (PAD)NCT02924857

The Chocolate Touch Study

A study testing Chocolate Touch and Lutonix Drug Coated Balloon in people with Peripheral Artery Disease (PAD) and Ischemia, run by TriReme Medical, LLC at 20 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Chocolate Touch and Lutonix Drug Coated Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
20 sitesin 4 countries
Study dates
26 Jul 2017to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 13Show fewer
  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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.)

Trial locations and contacts

20 sites in 4 countries.

20 sites in 4 countries

United States15 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Penn State Health Holy Spirit Medical Center

    Camp Hill, Pennsylvania, 17011

  • Univeristy Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Michigan Outpaitient Vascular Institution

    Dearborn, Michigan, 48126

  • Cardiac and Vascular Institute

    Gainesville, Florida, 32605

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • Jackson Heart

    Jackson, Mississippi, 39216

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Mt. Sinai - Miami

    Miami Beach, Florida, 33140

  • MIssion Research

    New Braunfels, Texas, 78130

  • Mt. Sinai Heart

    New York, New York, 10029

  • Columbia University Medical Center / NewYork Presbyterian Hospital

    New York, New York, 10032

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Pinnacle Health Cardiovascular Institute

    Wormleysburg, Pennsylvania, 17043

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Austria2 sites

  • Medical University of Graz - LKH Univ.-Klinikum Graz

    Graz, A-0836

  • Angiologie - Hansuchkrankenhaus

    Vienna, 1140

Other trials in Austria

New Zealand2 sites

  • Auckland City Hospital

    Auckland

  • Waikato Hospital

    Hamilton, 3210

Other trials in New Zealand

Germany1 site

  • Universitat Herz-Zentrum

    Bad Krozingen

Other trials in Germany

About this study

Official title: 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

Read the 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.

Being tested
Chocolate Touch, Lutonix Drug Coated Balloon
Medical subject headings
Peripheral Arterial Disease, Ischemia, Intermittent Claudication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chocolate TouchDevice

    Also called Chocolate Touch™ Paclitaxel Coated Balloon Catheter

    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.

  • Lutonix Drug Coated BalloonDevice

    Also called LUTONIX® 035 Drug Coated Balloon Catheter

    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.

Study groups in NCT02924857
Study groupRoleWhat they receive
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.
Receives: 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.
Receives: Device: Lutonix Drug Coated Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 12 months

  2. 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.

    Measured: 12 months

Secondary outcomes (3)

  1. 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

    Measured: 1 hour

  2. By Duplex Ultrasound Core Lab Review

    Patency

    Measured: 6, 12, 24, & 36 months

  3. By Clinical Assessment

    Occurrence of relevant Adverse Events

    Measured: 6, 12, 24, & 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2016 (estimated)
  2. Study start26 Jul 2017
  3. Primary completionJun 2025 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02924857
Sponsor's protocol ID
CLP788
Status last verified
Oct 2023
First submitted
3 Oct 2016
Last updated
30 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 15262830

  • 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.

    PubMed 11560536

  • 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.

    PubMed 17140820

  • 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.

    PubMed 16549646

  • 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.

    PubMed 17101615

  • 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.

    PubMed 18272892

  • 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.

    PubMed 18779447

  • 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.

    PubMed 24456716

  • 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.

    PubMed 21884945

  • 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.

    PubMed 23192918

  • 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.

    PubMed 20948503

  • Schnorr B, Speck U, Scheller B. Review of clinical data with Paccocath- coated balloon catheters. Minerva Cardioangiol. 2011 Oct;59(5):431-45.

    PubMed 21983304

  • 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.

    PubMed 21460774

  • 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.

    PubMed 8580930

  • 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.

    PubMed 35377157

Questions about this trial

What is this clinical trial studying?

A study testing Chocolate Touch and Lutonix Drug Coated Balloon in people with Peripheral Artery Disease (PAD) and Ischemia, run by TriReme Medical, LLC at 20 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Austria, New Zealand, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

True Drug Coated Balloon Success (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02924857, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.

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