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The Chocolate Touch Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02924857
Recruitment Status : Active, not recruiting
First Posted : October 5, 2016
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
TriReme Medical, LLC

Study Description
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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

Condition or disease Intervention/treatment Phase
Intermittent Claudication Ischemia Device: Chocolate Touch Device: Lutonix Drug Coated Balloon Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch™ Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines
Drug Information available for: Paclitaxel

Arms and Interventions
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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 Name: 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 Name: LUTONIX® 035 Drug Coated Balloon Catheter


Outcome Measures
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Primary Outcome Measures :
  1. True Drug Coated Balloon Success [ Time Frame: 12 months ]
    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).

  2. Freedom from Major Adverse Events [ Time Frame: 12 months ]
    Composite of target-limb-related death, major amputation of the target limb, and clinically driven re-intervention of the target limb.


Secondary Outcome Measures :
  1. By Angiographic Core Lab Review (Acute) [ Time Frame: 1 hour ]
    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

  2. By Duplex Ultrasound Core Lab Review [ Time Frame: 6, 12 & 24 months ]
    Patency

  3. By Clinical Assessment [ Time Frame: 1, 6, 12, & 24 months ]
    Occurrence of relevant Adverse Events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924857


Locations
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Sponsors and Collaborators
TriReme Medical, LLC
Investigators
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Principal Investigator: Mehdi Shishehbor, DO Cleveland Medical Center, Cleveland, Ohio
Principal Investigator: Thomas Zeller, MD Universitat Herzzentrum, Bad Krozingen, Germany
More Information
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Publications:
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. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: TriReme Medical, LLC
ClinicalTrials.gov Identifier: NCT02924857    
Other Study ID Numbers: CLP788
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Intermittent Claudication
Ischemia
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
 Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action