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

Catharina Hospital

Status

Terminated

Conditions

Peripheral Arterial Disease

Treatments

Procedure: Short spot stenting

Procedure: Long lesion stenting

Study type

Interventional

Funder types

Other

Identifiers

NCT03227822

NL43610.060.13 (Registry Identifier)

STRONG SFA study

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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