Symptomatic Vascular Disease of the Iliac ArteriesNCT01804088
FORMAT Clinical Study
A study testing Formula™ 535 Iliac Balloon-Expandable Stent in people with Symptomatic Vascular Disease of the Iliac Arteries, run by Cook Group Incorporated at 12 sites in United States.
Trial summary
The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of the iliac arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Vascular Disease of the Iliac Arteries
- What is being tested?
- Formula™ 535 Iliac Balloon-Expandable Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2013to 17 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Up to two documented common or external iliac artery lesions (one on each side), with >50% diameter stenosis, suitable for stenting
- iliac artery reference vessel diameter of 5-10 mm
- Rutherford Category 1, 2, 3, or 4.
Who cannot join
- Less than 18 years of age
- lesion site <10 or >100 mm in length
- external iliac artery lesion visually estimated to be 100% occluded
- presence of infrarenal aortic aneurysm >4 cm (treated or untreated)
- presence of any aneurysm (treated or untreated) within target vessel
- significant stenosis (>50%) or occlusion of inflow tract (infrarenal aortic lesions) not successfully treated before this procedure (success is measured as < 30% residual stenosis)
Show all 9Show fewer
- absence of at least one patent runoff vessel with ≤ 50% stenosis throughout its course (i.e., confirmed in-line patency to the level of the foot)
- angiographically evident thrombus within the target vessel (treated or untreated)
- lesion is in an iliac artery that has been previously stented
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
CardioVascular Solutions Institute
Bradenton, Florida, 34208
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio Health Research Institute
Columbus, Ohio, 43214
Indiana University Health - Methodist Hospital
Indianapolis, Indiana, 46202
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660
Scripps Health
La Jolla, California, 92037
University of Louisville
Louisville, Kentucky, 40202
New York-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065
Coastal Vascular and Interventional
Pensacola, Florida, 32503
Peoria Radiology Associates
Peoria, Illinois, 61602
Wake Heart Research (Rex Hospital)
Raleigh, North Carolina, 27610
About this study
Official title: Clinical Investigation of the Cook Formula™ 535 Iliac Balloon-Expandable Stent
The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of the iliac arteries.
- Being tested
- Formula™ 535 Iliac Balloon-Expandable Stent
- Keywords
- Peripheral artery disease, Iliac arteries, Balloon-expandable stent
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula™ 535 Iliac Balloon-Expandable StentDevice
Treatment of symptomatic vascular disease of the iliac arteries
| Study group | Role | What they receive |
|---|---|---|
| Stent | Experimental | Not described Receives: Device: Formula™ 535 Iliac Balloon-Expandable Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major adverse events
Measured: 9 months
Secondary outcomes (7)
Rate of technical success (i.e., successful delivery and deployment of a Formula™ 535 Iliac Balloon-Expandable Stent)
Measured: Intraoperative
Rate of acute procedure success(i.e.,vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events)
Measured: Postoperative until discharge (i.e., 0 to 4 days)
Rate of hemodynamic success(i.e., ABI or TBI improved above baseline)
Measured: 30 day, 9 month, 2 year, 3 year
30-day clinical success (i.e., vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events)
Measured: 30 day
Rate of primary patency (i.e.,the proportion of patients, over time, that have had uninterrupted patency since the initial procedure)
Measured: 30 day, 9 month, 2 year, 3 year
Rate of functional status improvement based on walking impairment questionnaire
Measured: 30 day, 9 month, 2 year, 3 year
Rate of improvement in Rutherford Category (i.e., improvement above baseline)
Measured: 30 day, 9 month, 2 year, 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2015
- Study completion17 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Vascular Disease of the Iliac ArteriesStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick J. Geraghty, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804088
- Sponsor's protocol ID
- 09-023
- Status last verified
- Feb 2018
- First submitted
- 1 Mar 2013
- Last updated
- 1 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Cook Formula™ 535 Iliac Balloon-Expandable Stent
- ClinicalTrials.gov ID
- NCT01804088
- Acronym / sponsor ID
- 09-023
- Keywords
- Peripheral artery disease, Iliac arteries, Balloon-expandable stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- 17 Jul 2017 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of the iliac arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stent | Experimental | Device: Formula™ 535 Iliac Balloon-Expandable Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Up to two documented common or external iliac artery lesions (one on each side), with >50% diameter stenosis, suitable for stenting
- iliac artery reference vessel diameter of 5-10 mm
- Rutherford Category 1, 2, 3, or 4.
Key exclusion criteria (9 listed)
- Less than 18 years of age
- lesion site <10 or >100 mm in length
- external iliac artery lesion visually estimated to be 100% occluded
- presence of infrarenal aortic aneurysm >4 cm (treated or untreated)
- presence of any aneurysm (treated or untreated) within target vessel
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 |
|---|---|---|
| Formula™ 535 Iliac Balloon-Expandable StentTreatment of symptomatic vascular disease of the iliac arteries | Device | Stent |
Primary outcome
Freedom from major adverse events
Time frame: 9 months
7 secondary outcomes
Rate of technical success (i.e., successful delivery and deployment of a Formula™ 535 Iliac Balloon-Expandable Stent)
Time frame: Intraoperative
Rate of acute procedure success(i.e.,vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events)
Time frame: Postoperative until discharge (i.e., 0 to 4 days)
Rate of hemodynamic success(i.e., ABI or TBI improved above baseline)
Time frame: 30 day, 9 month, 2 year, 3 year
30-day clinical success (i.e., vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events)
Time frame: 30 day
Rate of primary patency (i.e.,the proportion of patients, over time, that have had uninterrupted patency since the initial procedure)
Time frame: 30 day, 9 month, 2 year, 3 year
Rate of functional status improvement based on walking impairment questionnaire
Time frame: 30 day, 9 month, 2 year, 3 year
Rate of improvement in Rutherford Category (i.e., improvement above baseline)
Time frame: 30 day, 9 month, 2 year, 3 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
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.
Patrick J. Geraghty, MD principal investigator
Washington University School of Medicine
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formula™ 535 Iliac Balloon-Expandable Stent in people with Symptomatic Vascular Disease of the Iliac Arteries, run by Cook Group Incorporated at 12 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 3 inclusion and 9 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 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Freedom from major adverse events (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2018.