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Clinical Trials/NCT03227822
NCT03227822
Terminated
Not Applicable

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

Catharina Ziekenhuis Eindhoven0 sites3 target enrollmentJuly 2013
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ConditionsPeripheral Arterial Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
Catharina Ziekenhuis Eindhoven
Enrollment
3
Primary Endpoint
absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention
Status
Terminated
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
February 1, 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Catharina Ziekenhuis Eindhoven
Responsible Party
Principal Investigator
Principal Investigator

Marc van Sambeek

MD, PhD, vascular surgeon

Catharina Ziekenhuis Eindhoven

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

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

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