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

Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease; a Pilot Study

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 Overview

• Status: Terminated
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Short spot stenting; Procedure: Long lesion stenting

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short spot stenting	Procedure: Short spot stenting
Experimental: Long lesion stenting	Procedure: Long lesion stenting

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 5, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: STRONG SFA study; NL43610.060.13 (Registry Identifier: NL43610.060.13)