CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
Drug Coated Balloondevice
Likely dose
GORE® Drug-Coated PTA Balloon Catheter (specific dosing/diameter not specified in arms)AI-extracted
Key inclusion· 4
  • ✓Rutherford Class 2-4 peripheral artery disease
  • ✓De novo or restenotic lesions of the SFA/PA, including total occlusions
  • ✓Single lesion with ≥70% stenosis, 30-150mm combined length, 4-6mm reference vessel diameter
  • ✓At least one patent tibial or peroneal artery
Key exclusion· 7
  • ✕Prior treatment (surgical or endovascular) of target limb/vessel within 30 days
  • ✕Prior PTA of target lesion within 90 days or any prior drug-coated balloon treatment
  • ✕Prior stenting or bypass of target vessel
  • ✕Untreated iliac inflow lesions

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02907203
NCT02907203N/ACompleted
CompareCT.gov

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

W.L.Gore & Associates·interventional·Posted Sep 20, 2016·Updated Feb 8, 2023

In Brief

A clinical study evaluating Drug Coated Balloon for PAD. Completed, enrolled 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPAD
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 20, 2016
Enrollment StartOct 10, 2017
Primary CompletionMar 22, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.8 years ago

Interventions

Drug Coated Balloondevice

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.