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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03227822
Acronym
STRONG
Enrollment
3
Registered
2017-07-24
Start date
2013-07-31
Completion date
2015-02-01
Last updated
2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

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.

Interventions

PROCEDUREShort spot stenting
PROCEDURELong lesion stenting

Sponsors

Catharina Ziekenhuis Eindhoven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026