OCCLUDE-I: Evaluation of PerformanCe of the Peripheral EOS in the Treatment of Varicocele or Pelvic Congestion SynDromE

Sponsor

ArtVentive Medical Group, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02033863

Collaborator

(none)

Enrollment

Locations

Duration (Months)

13.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System.

Condition or Disease	Intervention/Treatment	Phase
Varicocele Pelvic Congestion Syndrome

Detailed Description

Prospective, non-randomized, multi-center confirmatory observational study for the treatment of subjects with the need for vascular occlusion for the following conditions:

Cohort A: Varicocele arising from the spermatic vein(s) and pampiniform plexus, with or without concomitant diagnosis of infertility or subfertility
Cohort B: Pelvic varices in females for the treatment of pelvic congestion syndrome (e.g., pelvic venous incompetence).

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

40 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

PrOspective, MultiCenter Study for the Evaluation of PerformanCe of the ArtVentive Medical Group Peripheral EndoLuminal OcclUsion SystemTM in the Treatment of Varicocele or Pelvic Congestion SynDromE - OCCLUDE I

Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Cohort A Varicocele arising from the spermatic vein(s) and pampiniform plexus, with or without concomitant diagnosis of infertility or subfertility
Cohort B Pelvic varices in females for the treatment of pelvic congestion syndrome (e.g., pelvic venous incompetence).

Outcome Measures

Primary Outcome Measures

Safety [Acute & 30 days]
Composite of new-onset major device-related adverse event(s) including device embolization beyond targeted treatment area (not therapeutic indication of embolization), need for emergency surgical intervention of the target vessel, or distal embolization (non-device embolization, e.g., particulate matter / plaque distal to the device) at 30 days.

Secondary Outcome Measures

Pain [Acute & 30 days]
Reduction of pain.
Recurrent varices [30 days]
Recurrence of varices requiring repeat embolizations within 30 days.
Occlusion [30 days]
Sustained occlusion at 30 days follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects aged ≥18 to ≤75 years.
Subject with target vessels of 3.0 mm to 12.0 mm in diameter.
Subject having indications to undergo embolotherapy consistent with clinical and pre-procedural angiographic assessment for spermatic vein origin varicocele (unilateral and/or bilateral) or pelvic congestion syndrome (pelvic venous incompetence).
Subject is able and willing to comply with site standard medical follow-up, including one month follow-up visit.
Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the consent form.

Exclusion Criteria:

Subject has an active systemic infection.
Subject has a known allergy to iodinated contrast for which they cannot be adequately premedicated.
Subject has history of stroke within the prior 6 months.
Subject has history of myocardial infarction with the prior 3 months.
Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of

2.5 mg/dL or >220 umol/L), or on dialysis.

Subject has a known coagulopathy or has a bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter, or INR >1.5.
Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g., severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression).
Subjects in whom venography or arteriography is contraindicated.
Subjects with known hypersensitivity or contraindication to nickel or nitinol.
Subject has a less than one year life expectancy.
Subject is pregnant or breastfeeding.
Subject with endometriosis or other ovarian / uterine pathology with adhesions that would interfere with the endpoints of this study.
Subject with previous pelvic surgical intervention or embolotherapy for varicocele or ovarian varices that would interfere with the endpoints of this study, including but not limited to, recurrent varicocele or ovarian varices.
Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.
Subject has planned concomitant procedure at the time of the embolization (e.g., coil embolization, etc.).
Subject is participating in another study of a device, medication, biologic, or other agent within 30 days or could, in the opinion of the investigator, impact the results of this study.
Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and or participating in evaluations pre- and post-treatment.