N/A N=108 Treatment

In-Stent Restenosis Post-Approval Study

Peripheral Artery Disease · Vascular Disease

Bottom Line

View on ClinicalTrials.gov: NCT02542267 ↗

Enrolled (actual)

108

Serious AEs

64.8%

Results posted

Aug 2020

Primary outcome: Primary: Primary Effectiveness — 0.715 Probability

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Gore VIABAHN Endoprosthesis (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: W.L.Gore & Associates
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Effectiveness	0.715	—
PRIMARY Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure	105	—
SECONDARY Number of Subjects With Acute Procedural Success	107	—
SECONDARY Primary Patency at 30 Days and 12, 24, and 36 Months	0.99; 0.715; 0.561; 0.449	—
SECONDARY Primary Assisted Patency at 30 Days and 12, 24, and 36 Months	1.00; 0.772; 0.643; 0.556	—
SECONDARY Secondary Patency at 30 Days and 12, 24, and 36 Months	1.00; 0.929; 0.822; 0.732	—
SECONDARY Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months	1.00; 0.828; 0.746; 0.668	—
SECONDARY Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months	1.00; 1.00; 1.00; 1.00	—
SECONDARY Change in Ankle Brachial Index at 30 Days	0.679; 1.004; 0.325	—
SECONDARY Change in Ankle Brachial Index at 1 Year	0.693; 0.921; 0.229	—
SECONDARY Change in Ankle Brachial Index at 2 Years	0.700; 0.913; 0.213	—
SECONDARY Change in Ankle Brachial Index at 3 Years	0.708; 0.937; 0.229	—
SECONDARY Change in Rutherford Category at 30 Days	3.2; 0.6; -2.5	—
SECONDARY Change in Rutherford Category at 1 Year	3.0; 0.8; -2.2	—
SECONDARY Change in Rutherford Category at 2 Years	3.1; 0.6; -2.4	—
SECONDARY Change in Rutherford Category at 3 Years	3.0; 0.8; -2.3	—
SECONDARY Stent Fracture at 12, 24, and 36 Months	0; 0; 0	—

Summary

The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.

Eligibility Criteria

Inclusion Criteria

Patient has a previously implanted (> 30 days) non-covered stent(s) located in the SFA
Patient has life-style limiting claudication, resting leg pain or minor tissue loss (Rutherford Category 2 - 5)
Patient demonstrates an Ankle Brachial Index (ABI) 0.9 or not measurable, patient is eligible for study if Toe Brachial Index is =50% in-stent restenosis and / or an occlusion in a previously implanted (>30 days) non-covered stent(s) located in the superficial femoral artery defined as beginning at least 1cm below the origin of the profunda femoris artery and ending at least 1cm above the intercondylar notch.
Patient has a maximum total lesion length of 270mm, consisting of in-stent and adjacent occlusive disease
Patient has a reference vessel diameter between 4.0 and 6.5mm
Patient has at least one patent infrapopliteal runoff vessel (<50% stenosis) not requiring reintervention
Note: Additional Inclusion Criteria may apply

Exclusion Criteria

Patient has a known allergy to stent graft components (nickel-titanium or expanded-polytetrafluoroethylene)
Patient has a known intolerance to anticoagulation or antiplatelet therapy
Patient has known coagulation disorder, including hypercoagulability.
Patient has major distal amputation (above the transmetatarsal)
Patient has any previous surgery in the target vessel
Patient has had previous target vessel in-stent restenosis treated by relining with another stent
Patient has untreated flow-limiting aortoiliac stenotic disease
Note: Additional Exclusion Criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02542267). 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.