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

NCT02907203 | Completed Results DMC

• 1 other identifier: DCB 15-02
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PAD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Subjects With Freedom From Major Adverse Events

  30 days

Study Arms (1)

Drug Coated Balloon

EXPERIMENTAL

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

Interventions

Drug Coated Balloon DEVICE

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.

Drug Coated Balloon

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PAD patients with Rutherford Class 2 - 4
• De novo or restenotic lesions, including total occlusions of the SFA/PA
• 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
• patent tibial or peroneal artery

You may not qualify if:

• 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)

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (1)

Universitats - Herzzentrum Freiburg

Bad Krozingen, Germany

Location

Results Point of Contact

• Title: Rizwan Afzal
• Organization: W. L. Gore and Associates

rafzal@wlgore.com

6236404888

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 20, 2016
• Study Start: October 10, 2017
• Primary Completion: March 22, 2022
• Study Completion: March 22, 2022
• Last Updated: February 8, 2023
• Results First Posted: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)