Short Spot Versus Long Lesion Stenting as Best Treatment... | NCT03227822

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

NCT03227822

Sponsor

Catharina Ziekenhuis Eindhoven

Status

Terminated

Last Update Posted

Oct 9, 2018Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Peripheral Arterial Disease

Interventions

Short spot stenting
Long lesion stenting

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NL43610.060.13	Registry Identifier	NL43610.060.13

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to include the number of patients

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Feb 1, 2015Actual

Completion Date

Feb 1, 2015Actual

First Submitted Date

Jul 21, 2017

First Submission Date that Met QC Criteria

Jul 21, 2017

First Posted Date

Jul 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2018

Last Update Posted Date

Oct 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Short spot stenting	Experimental	Short spot stenting	Procedure: Short spot stenting
Long lesion stenting	Experimental	Long lesion stenting	Procedure: Long lesion stenting

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Short spot stenting	Procedure		Short spot stenting
Long lesion stenting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided