SOLARIS Endoprosthesis in Iliac Occlusive Disease | NCT03606629

Studies
SOLARIS Endoprosthesis in Iliac Occlusive Disease

NCT03606629

Sponsor

Scitech Produtos Medicos SA

Status

Completed

Last Update Posted

May 10, 2022Actual

Enrollment

5Actual

Phase

Not provided

Conditions

Peripheral Arterial Disease

Interventions

Endoprosthesis implantation

Countries

Brazil

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

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2019Actual

Primary Completion Date

Apr 30, 2021Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Jul 20, 2018

First Submission Date that Met QC Criteria

Jul 20, 2018

First Posted Date

Jul 31, 2018Actual

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

May 7, 2022

Last Update Posted Date

May 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Fifty patients will be treated with Solaris Endoprosthesis and followed up to 2 years with Walking Impairment Questionnaire and Doppler Ultrasound evaluation in 30 days, 6 months and 12 months.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endoprosthesis implantation		Device implantation	Device: Endoprosthesis implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoprosthesis implantation	Device	Endoprosthesis implantation by Percutaneous Angioplasty	Endoprosthesis implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major Adverse Events	MAE is defined as death related to study device/ procedure, Myocardial Infarction, Target Vessel Revascularization or member amputation	1 day
Target Lesion Patency	Stenosis < 50% and systolic velocity up to 2.5 cm2/s and no TLR	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Rutherford Class 2 to 5;
Tasc II Class A, B, C or D;
Unilateral or bilateral lesion, de novo or restenotic but not in-stent;
Target lesion of 3 to 10 cm length;
≥ 50% stenosis or common iliac or external iliac artery;
Reference vessel diameter ≥ 5 and ≤ 9 mm;
Deep femoral artery patent and at least one infrapopliteal artery patent;
Informed Consent provided.

Exclusion Criteria:

Thrombocytopenia induced by heparina or tPA intravenous, clopidogrel, ticlopidine or aspirin sensitivity;
Target lesion near to aneurysm, highly calcified or excessively tortuous;
Previous stent on target vessel;
Presence of other lesions that need treatment within 30 days;
Rutherford Class 6;
Acute thrombotic occlusion;
History on amputation on the target limb.

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

Patients with POAD presenting limitant intermitent claudication after 6 months of clinical treatment and patients with rest ischemia, Rutherford class 2 to 5.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luiz Furuya, MD	Santa Casa de Misericórdia de Santo Amaro	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clínicas de Passo Fundo		Passo Fundo	Rio Grande do Sul		Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

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