The Chocolate Touch Study

Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02924857
• Other study ID #: CLP788
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 26, 2017
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: TriReme Medical, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 333
• Est. completion date: December 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Intermittent Claudication
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease (PAD)

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	Medical University of Graz - LKH Univ.-Klinikum Graz	Graz
Austria	Angiologie - Hansuchkrankenhaus	Vienna
Germany	Universitat Herz-Zentrum	Bad Krozingen
New Zealand	Auckland City Hospital	Auckland
New Zealand	Waikato Hospital	Hamilton
United States	Emory University	Atlanta	Georgia
United States	Penn State Health Holy Spirit Medical Center	Camp Hill	Pennsylvania
United States	Univeristy Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Michigan Outpaitient Vascular Institution	Dearborn	Michigan
United States	Cardiac and Vascular Institute	Gainesville	Florida
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Jackson Heart	Jackson	Mississippi
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Mt. Sinai - Miami	Miami Beach	Florida
United States	MIssion Research	New Braunfels	Texas
United States	Columbia University Medical Center / NewYork Presbyterian Hospital	New York	New York
United States	Mt. Sinai Heart	New York	New York
United States	Swedish Medical Center	Seattle	Washington
United States	Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
TriReme Medical, LLC

Countries where clinical trial is conducted

United States,  Austria,  Germany,  New Zealand, 

References & Publications (16)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	By Duplex Ultrasound Core Lab Review	Patency	6, 12, 24, & 36 months
Secondary	By Clinical Assessment	Occurrence of relevant Adverse Events	6, 12, 24, & 36 months