Safety and Feasibility of the Zotarolimus Stent in Treating Males With Erectile Dysfunction (ED) (ZEN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01643200
First received: July 16, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

Evaluate the safety and feasibility of the Medtronic Zotarolimus stent to improve erectile function in males with sub-optimal response to PDE5i therapy due to atherosclerotic lesions of the internal iliac and/or internal pudendal arteries.


Condition Intervention Phase
Erectile Dysfunction
Atherosclerosis
Device: Zotarolimus-Eluting Peripheral Stent System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Medtronic Zotarolimus-Eluting Peripheral Stent System for the Treatment of Erectile Dysfunction in Males With Sub-optimal Response to PDE5 Inhibitors

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Major Adverse Event (MAE) rate at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    MAE defined as: device and/or procedure related death, occurrence of perineal gangrene or necrosis (penile glans, penile shaft, scrotal or anal), perineal, penile or anal surgery (including target lesion or vessel revascularization or arterial embolization procedures).

  • IIEF Score Improvement [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    An improvement from pre-procedure in erectile function at 3 months as assessed by the erectile function domain score (Questions 1 - 5 and 15) of the International Index of Erectile Function (IIEF).


Secondary Outcome Measures:
  • Major Adverse Event (MAE) rate [ Time Frame: 3, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
    MAE rate measured at the 3, 6, 12, 24, 36, 48 and 60 month timepoints.

  • Changes in sexual function/IIEF [ Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Changes in sexual function from pre-procedure as assessed by the IIEF at 30 days, 6, 12, 24, 36, 48 and 60 months

  • Changes in sexual function/SEP [ Time Frame: From baseline, 30 days, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Changes in sexual function as assessed by the Sexual Encounter Profile (SEP) diary responses (SEP2 and SEP3) from baseline and measured as a percentage of successful attempts while on optimal PDE5i at 30 days, 3, 6, and 12 months

  • Mean Peak Systolic Velocity (PSV) [ Time Frame: 30 days, 6 and 12 months ] [ Designated as safety issue: No ]
    Mean peak systolic velocity (PSV) as assessed by duplex ultrasound (DUS) in the right and left cavernosal arteries at the mid-shaft during pharmacologically induced erection within 30 days and 6 and 12 months

  • Restenosis of the artery and integrity of the stent [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Restenosis and stent integrity as assessed by angiogram at 6 months

  • Penile rigidity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Penile rigidity as assessed by RigiScan at 6 months

  • Acute success rates [ Time Frame: Procedure through hospital discharge ] [ Designated as safety issue: Yes ]
    Device, lesion, and procedure success rates

  • Claudication evaluation [ Time Frame: From baseline through 30 days and 3, 6, and 12 months ] [ Designated as safety issue: Yes ]
    Claudication by vascular territory as assessed by change in Rutherford class by greater than or equal to 1 category from baseline at 30 days and 3, 6, and 12 months


Enrollment: 30
Study Start Date: October 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zotarolimus-Eluting Peripheral Stent
Zotarolimus-Eluting Peripheral Stent System
Device: Zotarolimus-Eluting Peripheral Stent System
Various lengths and diameters of the Zotarolimus-Eluting Peripheral Stent System

Detailed Description:

Stenting of the internal iliac and/or internal pudendal arteries as a treatment means to improve sexual performance.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males ≥ 18 years old in a stable heterosexual relationship for a minimum of 6 months prior to providing consent to participate in this study;
  • The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective investigational site;
  • The subject has successfully completed the 4 week run-in phase;
  • The subject has a mean PSV of the right and left cavernosal arteries;
  • The subject has angiographic evidence of an atherosclerotic stenosis of the internal iliac or internal pudendal artery;
  • The subject is able and willing to comply with all study requirements, including the follow-up evaluations and will return to the investigational site(s) for all required office visits.

Exclusion Criteria:

  • The subject has a life expectancy < 12 months;
  • The subject has erectile dysfunction associated with non-vascular (organic) etiology (i.e., psychogenic, mixed, neurologic abnormalities, untreated hormonal dysfunction, etc.);
  • The subject has untreated depression or hypertension;
  • The subject has any penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease) that in the investigator's opinion would impair sexual performance;
  • The subject's partner, according to the subject, has complaints of overall health such as cardiovascular or mental health concerns, or specific sexual health problems such as sexual interest, sexual arousal, orgasm or sexual pain issues;
  • The subject has a history of myocardial infarction, stroke or life-threatening arrhythmia, or unstable angina requiring hospitalization within 3 months prior to enrollment or is actively receiving nitrate therapy;
  • The subject has a known allergy or contraindication to any component (material, drug and/or polymer) of the stent system, aspirin, heparin or phenylepherine and/or a sensitivity to contrast media which cannot be adequately pre-medicated and/or is allergic to both clopidogrel and ticlopidine;
  • The subject has poorly controlled diabetes mellitus;
  • The subject has a history of bleeding diatheses or coagulopathy or will refuse blood transfusions;
  • The subject has received chemotherapy treatment within 12 months prior to enrollment;
  • The subject has a history of prior radiation therapy to the pelvic region, radical prostatectomy or cystectomy;
  • The subject has untreated hypogonadism;
  • The subject has known impaired renal function;
  • The subject has taken sildenafil or vardenafil within 24 hours or tadalafil within 36 hours prior to enrollment in the study;
  • The subject is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643200

Locations
United States, Illinois
Prairie Education and Research Cooperative
Springfield, Illinois, United States, 62701
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Krishna Rocha-Singh, MD Prairie Vascular Institute Springfield, IL
  More Information

No publications provided by Medtronic Endovascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01643200     History of Changes
Other Study ID Numbers: IP110
Study First Received: July 16, 2012
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:
Erectile Dysfunction
Male
Zotarolimus
Stent
Stenosis
Erection
PDE5 Inhibitors

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Erectile Dysfunction
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Phosphodiesterase 5 Inhibitors
Sirolimus
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014