The Sapheon Closure System Feasibility Study

This is a single center, prospective, non-randomized, feasibility study for the evaluation of safety, efficacy and performance of the Sapheon™ Closure System for the treatment of incompetent saphenous veins.

Study Overview

• Status: Completed
• Conditions: Venous Insufficiency of Leg
• Intervention / Treatment: Device: Sapheon™ Closure System

Detailed Description

Venous insufficiency of the lower extremities is a very common condition that is influenced by genetic and mechanical factors, and is a chronic and progressive disorder. The primary objectives for this clinical Study are to

1. demonstrate the safety of the Sapheon™ Closure System for the treatment of incompetent saphenous veins,
2. demonstrate the early and late efficacy of The Sapheon™ Closure System for the treatment of incompetent saphenous veins, and
3. demonstrate the satisfactory performance of the Sapheon™ Closure System device components.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Clinica Canela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males or non-pregnant females ≥21 years of age but <76 years of age.
• Venous reflux disease in the GSV diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging.
• Candidate for surgical closure of a segment of the GSV.
• CEAP classification of C2, C3 or C4.
• Ability to walk unassisted.
• Life expectancy of at least 18 months.
• Weight >110 lbs. (50 kg).
• Ability to attend follow-up visits.
• Ability to understand the investigational nature of the treatment, and to provide written informed consent.

Exclusion Criteria:

• Previous surgical procedure (surgical, thermal, or chemical ablation) associated with the venous segment to be treated.
• Diameter of index vein (Supine) <3mm or >12 mm in any segment.
• Tortuous GSV, which in the opinion of the Investigator will limit catheter placement.
• Local or systemic infection.
• Insulin dependent diabetes.
• Leg obesity impairing the ability to gain access to the treatment leg, and/or apply sufficient compression for treatment.
• Documented history of superficial or deep thrombophlebitis.
• Varicosities secondary to pelvic or abdominal tumor.
• Significant arterial insufficiency; demonstrated by absence of ankle pulse.
• Known sensitivity to the cyanoacrylate (CA) adhesive or positive reaction just prior to surgery (by injecting a small peripheral vein with the agent). The Study surgeon will judge the need for the injection and the subject's reaction to the injection on clinical grounds.
• Formal duplication of the saphenous trunk in the index vein (Accessory GSV segments allowed).
• Hypercoaguable state.
• Presence of incompetent perforators in the treatment length.
• History of right ventricular failure.
• Significant femoral or popliteal vein insufficiency.
• BMI >35
• Additional procedures in the treatment leg likely required within the six months after the investigational procedure.
• Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment.
• Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the Investigator may prevent safe participation or otherwise render the subject ineligible for the Study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sapheon™ Closure System; Sapheon™ Closure System for the treatment of incompetent saphenous veins.	Device: Sapheon™ Closure System; Sapheon™ Closure System for the treatment of incompetent saphenous veins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical Success	Evaluation of anatomic efficacy will be demonstrated by the absence of flow (Complete Closure) within the treated vein segment as determined by duplex ultrasound examination and will be performed in accordance with a standardized and detailed imaging protocol.	30 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint	Evaluation of safety will be assessed by the DSMB of all incidence of adverse events (procedure and non-procedure related; serious and non-serious)	Through 6 month follow-up

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: Claudia Bautista, MD, Clinica Canela

Publications and helpful links

General Publications

• Almeida JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle TM. Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology. 2015 Jul;30(6):397-404. doi: 10.1177/0268355514532455. Epub 2014 Apr 30.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: May 18, 2012
• First Submitted That Met QC Criteria: May 18, 2012
• First Posted (Estimate): May 22, 2012

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: April 29, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: CP-10669-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO