Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter) (DCB)

Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter) for Conformité Européene (CE) Mark Approval

This study will assess the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries of patients with symptomatic PAD.

Study Overview

• Status: Completed
• Conditions: PAD
• Intervention / Treatment: Device: Drug Coated Balloon

Detailed Description

The primary objective of the clinical investigation is to evaluate the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries (SFA/PA) of patients with symptomatic PAD.

The performance of the GORE® DCB Catheter is superior to a performance goal derived from literature reports of uncoated PTA balloons, measured six months after intervention.

• Study Type: Interventional
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Germany
  • Bad Krozingen, Germany
    • Universitats - Herzzentrum Freiburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• PAD patients with Rutherford Class 2 - 4
• De novo or restenotic lesions, including total occlusions of the SFA/PA
• 1 lesion which may include one or more regions of luminal narrowing ≥70% with a total combined lesion length between 30 - 150mm and a reference vessel diameter of 4 - 6mm
• 1 patent tibial or peroneal artery

Exclusion Criteria:

• Surgical or endovascular access in the Target limb/vessel within the previous 30 days
• Prior treatment of the Target lesion with PTA within 90 days or any prior treatment with drug-coated balloon
• Prior treatment of the Target vessel with stenting or bypass
• Iliac artery inflow lesions that cannot be successfully treated during the Index procedure
• Acute or subacute thrombus or arterial aneurysm in Target limb
• Severe calcification that renders the Target lesion non-dilatable
• Acute or chronic renal dysfunction (serum creatinine ≥2.5 mg/dL)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Drug Coated Balloon; Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.	Device: Drug Coated Balloon; Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late Lumen Loss (LLL)	Six month late lumen loss (LLL) is defined as the difference in minimum lumen diameter of the Target lesion between the time points immediately post-intervention and the 6-month follow-up angiography or at the time of a Clinically Driven Target Lesion Revascularization (CD TLR), whichever is earlier.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Freedom From Major Adverse Events	A composite 30-day safety endpoint of freedom from Major Adverse Events (MAE), defined as i) death, ii) Clinically-Driven Target Vessel Revascularization (CD TVR), or iii) amputation above the metatarsals, resulting from a vascular event, in the treated leg (Target limb amputation).	30 days

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2017
• Primary Completion (ACTUAL): March 22, 2022
• Study Completion (ACTUAL): March 22, 2022

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (ESTIMATE): September 20, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DCB 15-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO