NCT03227822

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

July 21, 2017

Last Update Submit

October 5, 2018

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

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

    1 year

Study Arms (2)

Short spot stenting

EXPERIMENTAL

Short spot stenting

Procedure: Short spot stenting

Long lesion stenting

EXPERIMENTAL

Long lesion stenting

Procedure: Long lesion stenting

Interventions

Short spot stentingPROCEDURE
Short spot stenting
Long lesion stentingPROCEDURE
Long lesion stenting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, vascular surgeon

Study Record Dates

First Submitted

July 21, 2017

First Posted

July 24, 2017

Study Start

July 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

October 9, 2018

Record last verified: 2018-10