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

July 16, 2012
July 10, 2014
October 2009
April 2016   (final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT01643200 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Safety and Feasibility of the Zotarolimus Stent in Treating Males With Erectile Dysfunction (ED)
The Medtronic Zotarolimus-Eluting Peripheral Stent System for the Treatment of Erectile Dysfunction in Males With Sub-optimal Response to PDE5 Inhibitors

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.

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

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Erectile Dysfunction
  • Atherosclerosis
Device: Zotarolimus-Eluting Peripheral Stent System
Various lengths and diameters of the Zotarolimus-Eluting Peripheral Stent System
Experimental: Zotarolimus-Eluting Peripheral Stent
Zotarolimus-Eluting Peripheral Stent System
Intervention: Device: Zotarolimus-Eluting Peripheral Stent System
Rogers JH, Goldstein I, Kandzari DE, Köhler TS, Stinis CT, Wagner PJ, Popma JJ, Jaff MR, Rocha-Singh KJ. Zotarolimus-eluting peripheral stents for the treatment of erectile dysfunction in subjects with suboptimal response to phosphodiesterase-5 inhibitors. J Am Coll Cardiol. 2012 Dec 25;60(25):2618-27. doi: 10.1016/j.jacc.2012.08.1016. Epub 2012 Nov 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
June 2016
April 2016   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01643200
IP110
Yes
Medtronic Endovascular
Medtronic Endovascular
Not Provided
Principal Investigator: Krishna Rocha-Singh, MD Prairie Vascular Institute Springfield, IL
Medtronic Endovascular
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP