N/A
N=50
The Complete® Self-Expanding Stent and Stent Delivery System Registry
Peripheral Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT00730730 ↗Enrolled (actual)
50
Serious AEs
10.0%
Results posted
Mar 2011
Primary outcome: Primary: The Number of Participants With Major Adverse Events (MAE) — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Complete SE Iliac Stent (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Endovascular
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Major Adverse Events (MAE) |
— | — |
| SECONDARY Number of Participants With Acute Success |
44 | — |
| SECONDARY Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success. |
46 | — |
| SECONDARY Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success. |
55 | — |
Summary
The purpose of this study is to show if a new delivery system with a modified stent is safe in treating occluded iliac arteries in patients with peripheral vascular disease. The modified Complete SE delivery system is hypothesized to assist physicians with more accurate stent placement reducing the likelihood of stent 'jumping' seen with the use of many self-expanding stent systems.
Eligibility Criteria
Inclusion Criteria
- The lesion(s) is either de-novo or restenotic in nature, located in either the common iliac artery or the external iliac artery and is >50% stenosed
- Target vessel reference diameter ≥ 4.5 mm and ≤ 9.5 and can accommodate stent diameters of 6.0 - 10.0mm
- Subject is either asymptomatic with a lesion stenosis ≥70% or symptomatic with a lesion stenosis ≥50% with an Ankle Brachial Index (ABI) 700,000 cells/mm3, or White Blood Count (WBC) 2.0 mg/dl;
- Participation in another investigational device or drug study and has not completed the primary endpoint(s) follow-up phase of that study at least 30 days prior to enrollment in this trial or the subject has previously been enrolled in this Registry;
Data sourced from ClinicalTrials.gov (NCT00730730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.