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NCT03227822 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

— STRONG  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03227822
Other study ID # STRONG SFA study
Secondary ID NL43610.060.13
Status Terminated
Phase N/A
First received
Last updated
Start date July 2013
Est. completion date February 1, 2015

Study information
Verified date October 2018
Source Catharina Ziekenhuis Eindhoven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 3
Est. completion date February 1, 2015
Est. primary completion date February 1, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Short spot stenting

• Long lesion stenting

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Catharina Ziekenhuis Eindhoven

Outcome
Type Measure Description Time frame Safety issue
Primary absence of binary restenosis (= 50% re-obstruction) of the target lesion without interval clinically driven reintervention 1 year
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