The Sapheon Closure System Feasibility Study

Venous Insufficiency of Leg Clinical Trial

Official title:

The Sapheon Closure System Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603433
• Other study ID #: CP-10669-01
• Status: Completed
• Phase: N/A
• First received: May 18, 2012
• Last updated: April 29, 2016
• Start date: July 2011
• Est. completion date: July 2014

Study information

• Verified date: April 2016
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Dominican Republic: Consejo Nacional de Bioetica en SaludDominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 76 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Venous Insufficiency
• Venous Insufficiency of Leg

Intervention

Device:
• Sapheon™ Closure System
Sapheon™ Closure System for the treatment of incompetent saphenous veins.

Locations

Country	Name	City	State
Dominican Republic	Clinica Canela	Santo Domingo

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes