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

NCT ID: NCT03227822

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-02-01

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short spot stenting

Short spot stenting

Group Type: EXPERIMENTAL

Short spot stenting

Intervention Type: PROCEDURE

Long lesion stenting

Long lesion stenting

Group Type: EXPERIMENTAL

Long lesion stenting

Intervention Type: PROCEDURE

Interventions

Short spot stenting

Intervention Type: PROCEDURE

Long lesion stenting

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

Marc van Sambeek

MD, PhD, vascular surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

NL43610.060.13

Identifier Type: REGISTRY

Identifier Source: secondary_id

STRONG SFA study

Identifier Type: -

Identifier Source: org_study_id