Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial

NCT02129127 | Completed DMC

• 1 other identifier: CLP004
• Study Type: interventional
• Target: 67
• Locations: 2 countries
• Sites: 2

Brief Summary

This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease. The study focuses on acute device performance and peri-procedural safety and also seeks to further characterize the performance of the device.

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Late Lumen Loss (LLL)

  LLL is determined by assessing the difference between the minimum lumen diameter (MLD) immediately after treatment with the DCC and the MLD at angiographic follow-up. LLL will determined by the Angiographic Core Laboratory.

  3 Months (BTK) or 6 Months (ATK)

Secondary Outcomes (6)

• Device Success

  approx 1 hour

• Technical Success

  approx 1 hour

• Device Related Adverse Events (AEs)

  30 days

• Freedom from Target Lesion Revascularization (TLR)

  30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)

• Amputation Free Survival

  30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)

Study Arms (1)

Drug Coated Chocolate

EXPERIMENTAL

Paclitaxel Coated Chocolate Balloon Angioplasty

Device: Paclitaxel Coated Chocolate Balloon Angioplasty

Interventions

Paclitaxel Coated Chocolate Balloon Angioplasty DEVICE

Balloon Angioplasty with the Chocolate Balloon resulting in vessel dilatation and localized delivery of Paclitaxel

Drug Coated Chocolate

Eligibility Criteria

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

You may qualify if:

• Intermittent claudication or critical limb ischemia
• Atherosclerotic target lesion \>70% stenosis
• Reference vessel diameter (RVD) between 2.0 and 6.0mm
• Angiographic evidence of distal run-off
• Target lesion length \<150mm 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 DCC devices

You may not qualify if:

• Acute limb ischemia or thrombolytic therapy
• Known and relevant allergies/hypersensitivities
• Known impaired renal function
• Known bleeding disorder
• Severe calcification at the target lesion
• Previous bypass or stent at, or proximal to, target vessel
• Aneurysm in target limb
• Prior major limb amputation
• Use of a any of the following: re-entry device, atherectomy, laser or other ablation procedure, or cutting/scoring balloon at the target lesion; use of drug eluting stent, or non-study drug coated balloon in the target limb.

Sponsors & Collaborators

• TriReme Medical, LLC: lead

Study Sites (2)

Universitats Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Location

Auckland City Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andrew Holden, MD

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

• Thomas Zeller, MD

  Universitats Herzzentrum Bad Krozingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 2, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: April 1, 2017
• Last Updated: April 14, 2017

Record last verified: 2017-04

Locations

DE (1); NZ (1)