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

Not Applicable

Terminated

• Conditions: Peripheral Arterial Disease
• Interventions: Procedure: Long lesion stenting; Procedure: Short spot stenting

• Registration Number: NCT03227822
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2015-02-01
• Study Completion: 2015-02-01
• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-24
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-05
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long lesion stenting	Long lesion stenting	Long lesion stenting
Short spot stenting	Short spot stenting	Short spot stenting

Primary Outcome Measures

Name	Time	Method
absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention	1 year