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

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

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

Study Overview

• Status: Unknown
• Conditions: 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:

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

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • UZ Leuven
• Poland
  • Lubin, Poland
    • University Hospital No4
• Switzerland
  • Lugano, Switzerland
    • Ospedale Regionale di Lugano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects requiring permanent occlusion of the peripheral vessels for the following conditions:

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

Description

Inclusion Criteria:

1. Subjects aged ≥18 to ≤75 years.
2. Subject with target vessels of 3.0 mm to 12.0 mm in diameter.
3. 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).
4. Subject is able and willing to comply with site standard medical follow-up, including one month follow-up visit.
5. 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:

1. Subject has an active systemic infection.
2. Subject has a known allergy to iodinated contrast for which they cannot be adequately premedicated.
3. Subject has history of stroke within the prior 6 months.
4. Subject has history of myocardial infarction with the prior 3 months.
5. 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.
6. Subject has a known coagulopathy or has a bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter, or INR >1.5.
7. 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).
8. Subjects in whom venography or arteriography is contraindicated.
9. Subjects with known hypersensitivity or contraindication to nickel or nitinol.
10. Subject has a less than one year life expectancy.
11. Subject is pregnant or breastfeeding.
12. Subject with endometriosis or other ovarian / uterine pathology with adhesions that would interfere with the endpoints of this study.
13. 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.
14. Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.
15. Subject has planned concomitant procedure at the time of the embolization (e.g., coil embolization, etc.).
16. 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.
17. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	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.	Acute & 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Reduction of pain.	Acute & 30 days
Recurrent varices	Recurrence of varices requiring repeat embolizations within 30 days.	30 days
Occlusion	Sustained occlusion at 30 days follow-up.	30 days

Collaborators and Investigators

• Sponsor: ArtVentive Medical Group, Inc.
• Investigators: Principal Investigator: Geert Maleux, MD, UZ Leuven, Belgium

Publications and helpful links

General Publications

• Venbrux AC, Rudakov L, Plass A, Emmert MY, Ebner A. A new occlusion device: application of the ArtVentive endoluminal occlusion system (EOS)--first in human clinical trial. Cardiovasc Intervent Radiol. 2014 Feb;37(1):85-93. doi: 10.1007/s00270-013-0626-y. Epub 2013 May 24.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimate): January 13, 2014

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Varicocele; Pelvic Congestion Syndrome; Pelvic Venous Incompetence; Ovarian Varices
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Varicocele
• Other Study ID Numbers: TD 0080/07