Peripheral Vascular DiseaseNCT00730730

The Complete® Self-Expanding Stent and Stent Delivery System Registry

A study testing Complete SE Iliac Stent in people with Peripheral Vascular Disease, run by Medtronic Endovascular at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Vascular Disease
What is being tested?: Complete SE Iliac Stent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 2 sitesUnited States
Study dates: Nov 2007to Aug 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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) < 0.90 or Toe Brachial Index (TBI) <0.80 or an abnormal Pulse Volume Recording (PVR);
Total lesion length is < 110 mm;

Who cannot join

Excessive Peripheral Vascular Disease (PVD), unresolved fresh thrombus or tortuosity or a target lesion/vessel that is heavily calcified ;
Tissue loss in the extremity: category 5 or 6 on the Rutherford scale;
Target lesion has a previous stent, or is within a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis;
Target lesion is within an aneurysm or associated with an aneurysm in the vessel segment proximal or distal to the target lesion;
Lesion requires treatment with a non-standard device associated with Percutaneous Transluminal Angioplasty (PTA) prior to stent placement;
Inadequate distal run-off;

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Planned interventional procedure or vascular surgery to target vessel within 30 days pre- or post-index iliac procedure;
History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
Platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or White Blood Count (WBC) <3,000 cells/mm3;
Creatinine >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;

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Michigan Vascular Research Center
Flint, Michigan, 48507
New York Presbyterian Hospital, Columbia Campus
New York, New York, 10032

Other trials in United States

About this study

Official title: The Medtronic Complete® Self-Expanding Stent and Stent Delivery System Registry: a Non-randomized Prospective, Multicenter, Consecutive Registry

Read the detailed description

The study is being conducted to collect the 30-day safety data on the stent delivery system for all subjects enrolled into the study (with a minimum of 50 subjects enrolled) as well as the long-term 9-month safety and efficacy data on all subjects enrolled (with a minimum of 10 subjects enrolled into the study having the 120mm length stent implanted).

Conditions: Peripheral Vascular Disease
Being tested: Complete SE Iliac Stent
Keywords: Iliac Artery, Peripheral Vascular Disease (PVD)
Medical subject headings: Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Complete SE Iliac StentDevice
Iliac stenting
Complete SE Iliac StentDevice
Self-expanding stent

Study groups in NCT00730730
Study group	Role	What they receive
Complete SE Iliac Stent	Experimental	Complete SE Iliac Stent Receives: Device: Complete SE Iliac Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number of Participants With Major Adverse Events (MAE)
Major adverse events (MAE) defined as any death, target limb loss or clinically-driven Target Lesion Revascularization (TLR)/Target Vessel Revascularization (TVR) with percutaneous transluminal angioplasty or aorto-iliac bypass graft) for all subjects enrolled into the registry
Measured: 30 days

Secondary outcomes (3)

Number of Participants With Acute Success
angiographic evidence of < 30 % final residual stenosis of the target lesion after stent placement with no occurrence of a device- related, procedure-related MAE or vascular event (stent thrombosis, major bleeding complications)
Measured: from after stent placement to prior to hospital discharge (up to 3 days)
Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success.
Improvement of Rutherford scale by ≥ 1 category between pre-procedure (Baseline) and 30-day follow-up-
- Category 0: Asymptomatic, no hemodynamically significant occlusive disease;
- Category 1: Mild claudication;
- Category 2: Moderate claudication;
- Category 3: Severe claudication;
- Category 4: Ischemic rest pain;
- Category 5: Minor tissue loss; non-healing ulcer; focal gangrene with diffuse pedal ischemia;
- Category 6: Major tissue loss extending above transmetatarsal level;functional foot no longer salvageable
Measured: From baseline up to 30-days
Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success.
Improvement in ankle-brachial index (ABI) or toe-brachial index (TBI) > 0.10 over pre-procedure level OR deterioration by ≤ 0.15 from first post-procedure exam OR pulse volume recording (PVR) distal to the target lesion treated maintained at ≥ 5 mm above pre-procedure tracing for those subjects with no pre-procedure ABI/TBI.
An ABI ≥ 0.90 is considered normal.
Measured: From baseline up to 30-days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Aug 2012

First posted8 Aug 2008 (estimated)
Study startNov 2007
Primary completionFeb 2009
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00730730
Sponsor's protocol ID: IP084
Other IDs: IDE G070114
Status last verified: Feb 2016
First submitted: 5 Aug 2008
Last updated: 4 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
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All Peripheral Vascular Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Medtronic Complete® Self-Expanding Stent and Stent Delivery System Registry: a Non-randomized Prospective, Multicenter, Consecutive Registry
ClinicalTrials.gov ID: NCT00730730
Acronym / sponsor ID: IP084
Conditions: Peripheral Vascular Disease
Keywords: Iliac Artery, Peripheral Vascular Disease (PVD)
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Medtronic EndovascularIndustry (pharma, biotech, devices)
Collaborators: Medtronic
Study start: Nov 2007
Primary completion: Feb 2009 (actual)
Study completion: Aug 2012 (actual)
First posted: 8 Aug 2008 (estimated)
Results: Posted 11 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Complete SE Iliac Stent	Experimental	Device: Complete SE Iliac StentComplete SE Iliac Stent

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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) < 0.90 or Toe Brachial Index (TBI) <0.80 or an abnormal Pulse Volume Recording (PVR);
Total lesion length is < 110 mm;

Key exclusion criteria (11 listed)

Excessive Peripheral Vascular Disease (PVD), unresolved fresh thrombus or tortuosity or a target lesion/vessel that is heavily calcified ;
Tissue loss in the extremity: category 5 or 6 on the Rutherford scale;
Target lesion has a previous stent, or is within a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis;
Target lesion is within an aneurysm or associated with an aneurysm in the vessel segment proximal or distal to the target lesion;
Lesion requires treatment with a non-standard device associated with Percutaneous Transluminal Angioplasty (PTA) prior to stent placement;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Complete SE Iliac StentIliac stenting	Device	Complete SE Iliac Stent
Complete SE Iliac StentSelf-expanding stent	Device	Complete SE Iliac Stent

Primary outcome

The Number of Participants With Major Adverse Events (MAE)
Time frame: 30 days
Major adverse events (MAE) defined as any death, target limb loss or clinically-driven Target Lesion Revascularization (TLR)/Target Vessel Revascularization (TVR) with percutaneous transluminal angioplasty or aorto-iliac bypass graft) for all subjects enrolled into the registry

3 secondary outcomes

Number of Participants With Acute Success
Time frame: from after stent placement to prior to hospital discharge (up to 3 days)
Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success.
Time frame: From baseline up to 30-days
Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success.
Time frame: From baseline up to 30-days

Results and safety

Results posted to the registry on 11 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Complete SE Iliac Stent	50	50

Primary outcome: The Number of Participants With Major Adverse Events (MAE)

Time frame: 30 days. Number. Unit: participants

Measure	Complete SE Iliac Stent n = 50
Value	0

Population analysed: Intent-to-treat population (ITT)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iliac Stenting	5 of 50 (10%)	4 of 50 (8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Peripheral Vascular Disease

Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
RecruitingObservational study
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature
Peripheral Vascular Diseases

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert G Molnar, MD principal investigator

Michigan Vascular Research Center

William Gray principal investigator

New York Presbyterian Hospital/Columbia Campus

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Complete SE Iliac Stent in people with Peripheral Vascular Disease, run by Medtronic Endovascular at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of Participants With Major Adverse Events (MAE) (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00730730.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016; AzTrials last refreshed its copy on 6 Nov 2026.