Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease

Catharina Ziekenhuis Eindhoven3 enrolled

Overview

Since the length of lesion seems to be negatively associated with stent patency due to restenosis, it is thought that the efficacy of treatment in patients with multiple (\> 1) short (focal; \> 1 and \< 5 cm) SFA lesions can be improved by spot stenting as compared to the use of one long stent. This study proposes to evaluate the endovascular treatment for patients with SFA lesions by comparing two strategies for patients with extensive occlusive SFA disease; 1) short spot (SS) stenting or 2) long lesion (LL) stenting.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Disease

Interventions

Short spot stentingPROCEDURE

Long lesion stentingPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * PAOD (ABI \<0.90 and/or a decline of \>0.15 after exercise test), Rutherford category 2, 3 or 4 * Multiple (\>1) short (focal; \>1 and \< 5 cm) significant stenoses (≥ 50%) and/or occlusions in the superficial femoral artery * Eligible for endovascular treatment via short spot stenting and via long lesion stenting according to international guidelines * Unilateral occlusive disease * Age ≥ 18 Exclusion Criteria: * Patients with PAOD Rutherford category 5 and 6 * Impaired inflow due to significant lesions in the arteries proximal to the SFA intended to treat * Bilateral lesions with treatment indication * Contra-indication for anticoagulant therapy * Renal insufficiency (MDRD \< 50 ml/min) * Life expectancy \< 6 months * Known contrast allergy * Pregnancy * Unable to complete a questionnaire in the home language

Outcomes

Primary Outcomes

absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention

Time frame: 1 year

Data from ClinicalTrials.gov

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