N/A Completed N=52 Treatment

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

PAD

Source: ClinicalTrials.gov NCT02907203 ↗

Enrolled (actual)

Serious AEs

51.9%

Results posted

Feb 2023

Primary outcomePrimary: Late Lumen Loss (LLL) — -0.17 mm — p=0.000

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Late Lumen Loss (LLL)	-0.17	0.000 sig
SECONDARY Number of Subjects With Freedom From Major Adverse Events	52	—

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02907203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.