Peripheral Arterial DiseaseIVUS-PADNCT02037113
Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance
An observational study of Peripheral Arterial Disease, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
This is a prospective, single-center study. The patients with peripheral arterial disease who underwent abdominal aortograms with runoff (which are arteriograms of the lower abdominal aorta and arteries in the legs) and Intravascular Ultrasound after stent deployment will be enrolled in the study. Read more about this study
- Who is it for?
- Ages 25 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Aug 2016
- Phase
- Observational
- 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 25 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients who have peripheral arterial disease and underwent elective abdominal aortograms with runoff with peripheral artery intervention in University Medical Center hospital, Lubbock Texas, during January 2014 to December 30, 2015.
Who may be able to join
- 25-89 years of age
- Admitted for elective abdominal aortograms with runoff.
- Underwent Angioplasty and/or atherectomy with stent placement for Femoro-popliteal disease.
- Intravascular ultrasound was performed after stent deployment.
Who cannot join
- Patients who had prior Femoro-popliteal artery surgery or bypass in the same limb.
- Stent placement for lesions above inguinal ligament or below popliteal artery.
- The patient who presented with acute limb ischemia.
- Unable to follow-up in TTUHSC clinic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
Official title: Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance (CRI14-007)
This is a prospective, single-center study. The patients with peripheral arterial disease who underwent abdominal aortograms with runoff (which are arteriograms of the lower abdominal aorta and arteries in the legs) and Intravascular Ultrasound after stent deployment will be enrolled in the study. All patients who participated in the study will be treated according to standard of care.
HYPOTHESIS The higher degree of plaque burden on landing zone has an effect on restenosis on peripheral artery intervention.
Read more
SPECIFIC AIMS
- To determine intravascular ultrasound parameters of stent deployment and outcomes of Femoro-popliteal Disease
- To determine clinical risk factors and outcomes of Femoro-popliteal Disease
- To obtain data that will eventually support development of a predictive model for ISR in Femoro-popliteal Disease
METHODOLOGY Visit 1: After consent is given
The subject will receive standard follow-up care. A member of the research team will collect information such as the subject's age, sex, ethnicity, and medical information from the subject's medical record.
Visits 2-5: 1 day after enrollment, and at months 3 (+- 2 weeks), 6 (+- 2 weeks), and 12 (+- 2 weeks)
The subject will complete standard follow-up appointment at TTUHSC. This may include a Doppler ultrasound.
A member of the research team will record information such as medications, ultrasounds, and need for additional care related to the subject's stent.
The subject will complete the questionnaire on leg pain and mobility.
Read the detailed description
SUBJECT POPULATION:
- The patients who have peripheral arterial disease and underwent elective abdominal aortograms with runoff with peripheral artery intervention in University Medical Center hospital, Lubbock Texas, during January 2014 to December 30, 2015.
INCLUSION CRITERIA:
- 25-89 years of age
- Admitted for elective abdominal aortograms with runoff.
- Underwent Angioplasty and/or atherectomy with stent placement for Femoro-popliteal disease.
- Intravascular ultrasound was performed after stent deployment.
EXCLUSION CRITERIA:
- Patients who had prior Femoro-popliteal artery surgery or bypass in the same limb.
- Stent placement for lesions above inguinal ligament or below popliteal artery.
- The patient who presented with acute limb ischemia.
- Unable to follow-up in TTUHSC clinic.
- Conditions
- Peripheral Arterial Disease
- Keywords
- IVUS, PAD, Femoro-popliteal disease, Intravascular ultrasound
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patient underwent PAD-Stent | Patient who underwent angioplasty and/or atherectomy with stent placement for Femoro-popliteal disease and Intravascular ultrasound was performed after stent deployment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In Stent Restenosis
Measured: 1 years
Redo procedure
Measured: 1 year
Early and late stent thrombosis
Measured: 1 year
Acute ischemic event
Measured: 1 year
Secondary outcomes (1)
All causes mortality
to be obtained from UMC Cath-Lab NCDR registry
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: PI left institution--only 8 subjects were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Suarez, MD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037113
- Sponsor's protocol ID
- L14-047
- Acronym
- IVUS-PAD
- Status last verified
- Mar 2018
- First submitted
- 13 Jan 2014
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.
PubMed 2950322Conte MS, Bandyk DF, Clowes AW, Moneta GL, Seely L, Lorenz TJ, Namini H, Hamdan AD, Roddy SP, Belkin M, Berceli SA, DeMasi RJ, Samson RH, Berman SS; PREVENT III Investigators. Results of PREVENT III: a multicenter, randomized trial of edifoligide for the prevention of vein graft failure in lower extremity bypass surgery. J Vasc Surg. 2006 Apr;43(4):742-751; discussion 751. doi: 10.1016/j.jvs.2005.12.058.
PubMed 16616230Reifsnyder T, Grossman JP, Leers SA. Limb loss after lower extremity bypass. Am J Surg. 1997 Aug;174(2):149-51. doi: 10.1016/s0002-9610(97)90074-x.
PubMed 9293832Sullivan TM, Childs MB, Bacharach JM, Gray BH, Piedmonte MR. Percutaneous transluminal angioplasty and primary stenting of the iliac arteries in 288 patients. J Vasc Surg. 1997 May;25(5):829-38; discussion 838-9. doi: 10.1016/s0741-5214(97)70212-x.
PubMed 9152310Martinez R, Rodriguez-Lopez J, Diethrich EB. Stenting for abdominal aortic occlusive disease. Long-term results. Tex Heart Inst J. 1997;24(1):15-22.
PubMed 9068134Leon LR Jr, Dieter RS, Gadd CL, Ranellone E, Mills JL Sr, Montero-Baker MF, Gruessner AC, Pacanowski JP Jr. Preliminary results of the initial United States experience with the Supera woven nitinol stent in the popliteal artery. J Vasc Surg. 2013 Apr;57(4):1014-22. doi: 10.1016/j.jvs.2012.10.093.
PubMed 23535039Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.
PubMed 16672699
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance (CRI14-007)
- ClinicalTrials.gov ID
- NCT02037113
- Acronym / sponsor ID
- IVUS-PAD / L14-047
- Conditions
- Peripheral Arterial Disease
- Keywords
- IVUS, PAD, Femoro-popliteal disease, Intravascular ultrasound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution--only 8 subjects were enrolled.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Jan 2014 (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.
This is a prospective, single-center study. The patients with peripheral arterial disease who underwent abdominal aortograms with runoff (which are arteriograms of the lower abdominal aorta and arteries in the legs) and Intravascular Ultrasound after stent deployment will be enrolled in the study. All patients who participated in the study will be treated according to standard of care.
HYPOTHESIS The higher degree of plaque burden on landing zone has an effect on restenosis on peripheral artery intervention.
SPECIFIC AIMS
- To determine intravascular ultrasound parameters of stent deployment and outcomes of Femoro-popliteal Disease
- To determine clinical risk factors and outcomes of Femoro-popliteal Disease
- To obtain data that will eventually support development of a predictive model for ISR in Femoro-popliteal Disease
METHODOLOGY Visit 1: After consent is given
The subject will receive standard follow-up care. A member of the research team will collect information such as the subject's age, sex, ethnicity, and medical information from the subject's medical record.
Visits 2-5: 1 day after enrollment, and at months 3 (+- 2 weeks), 6 (+- 2 weeks), and 12 (+- 2 weeks)
The subject will complete standard follow-up appointment at TTUHSC. This may include a Doppler ultrasound.
A member of the research team will record information such as medications, ultrasounds, and need for additional care related to the subject's stent.
The subject will complete the questionnaire on leg pain and mobility.
Detailed description
SUBJECT POPULATION:
- The patients who have peripheral arterial disease and underwent elective abdominal aortograms with runoff with peripheral artery intervention in University Medical Center hospital, Lubbock Texas, during January 2014 to December 30, 2015.
INCLUSION CRITERIA:
- 25-89 years of age
- Admitted for elective abdominal aortograms with runoff.
- Underwent Angioplasty and/or atherectomy with stent placement for Femoro-popliteal disease.
- Intravascular ultrasound was performed after stent deployment.
EXCLUSION CRITERIA:
- Patients who had prior Femoro-popliteal artery surgery or bypass in the same limb.
- Stent placement for lesions above inguinal ligament or below popliteal artery.
- The patient who presented with acute limb ischemia.
- Unable to follow-up in TTUHSC clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient underwent PAD-Stent | – | –Patient who underwent angioplasty and/or atherectomy with stent placement for Femoro-popliteal disease and Intravascular ultrasound was performed after stent deployment. |
Who may qualify
- Ages
- 25 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who have peripheral arterial disease and underwent elective abdominal aortograms with runoff with peripheral artery intervention in University Medical Center hospital, Lubbock Texas, during January 2014 to December 30, 2015.
Key inclusion criteria (4 listed)
- 25-89 years of age
- Admitted for elective abdominal aortograms with runoff.
- Underwent Angioplasty and/or atherectomy with stent placement for Femoro-popliteal disease.
- Intravascular ultrasound was performed after stent deployment.
Key exclusion criteria (4 listed)
- Patients who had prior Femoro-popliteal artery surgery or bypass in the same limb.
- Stent placement for lesions above inguinal ligament or below popliteal artery.
- The patient who presented with acute limb ischemia.
- Unable to follow-up in TTUHSC clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In Stent Restenosis
Time frame: 1 years
Redo procedure
Time frame: 1 year
Early and late stent thrombosis
Time frame: 1 year
Acute ischemic event
Time frame: 1 year
1 secondary outcome
All causes mortality
Time frame: 1 year
Results and safety
The study was stopped early (reason given: PI left institution--only 8 subjects were enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Background: PubMed 2950322Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.
- Background: PubMed 16616230Conte MS, Bandyk DF, Clowes AW, Moneta GL, Seely L, Lorenz TJ, Namini H, Hamdan AD, Roddy SP, Belkin M, Berceli SA, DeMasi RJ, Samson RH, Berman SS; PREVENT III Investigators. Results of PREVENT III: a multicenter, randomized trial of edifoligide for the prevention of vein graft failure in lower extremity bypass surgery. J Vasc Surg. 2006 Apr;43(4):742-751; discussion 751. doi: 10.1016/j.jvs.2005.12.058.
- Background: PubMed 9293832Reifsnyder T, Grossman JP, Leers SA. Limb loss after lower extremity bypass. Am J Surg. 1997 Aug;174(2):149-51. doi: 10.1016/s0002-9610(97)90074-x.
- Background: PubMed 9152310Sullivan TM, Childs MB, Bacharach JM, Gray BH, Piedmonte MR. Percutaneous transluminal angioplasty and primary stenting of the iliac arteries in 288 patients. J Vasc Surg. 1997 May;25(5):829-38; discussion 838-9. doi: 10.1016/s0741-5214(97)70212-x.
- Background: PubMed 9068134Martinez R, Rodriguez-Lopez J, Diethrich EB. Stenting for abdominal aortic occlusive disease. Long-term results. Tex Heart Inst J. 1997;24(1):15-22.
- Background: PubMed 23535039Leon LR Jr, Dieter RS, Gadd CL, Ranellone E, Mills JL Sr, Montero-Baker MF, Gruessner AC, Pacanowski JP Jr. Preliminary results of the initial United States experience with the Supera woven nitinol stent in the popliteal artery. J Vasc Surg. 2013 Apr;57(4):1014-22. doi: 10.1016/j.jvs.2012.10.093.
- Background: PubMed 16672699Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.
- Individual participant dataSharing planned: No
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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.
Alex Suarez, MD principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Texas Tech University Health Sciences Center at 1 site 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 4 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: stopped early, as of the sponsor's last update on 21 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 1 site 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 was stopped early (reason given: PI left institution--only 8 subjects were enrolled.). Results are not available in the source record.
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?
In Stent Restenosis (time frame: 1 years). The study lists 4 primary outcomes in all. 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 NCT02037113, which also lists 7 linked publications.
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 21 Mar 2018.