Critical Limb IschemiaLIMBSAVENCT01799811
Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia for Peripheral Revascularization
An observational study of Critical Limb Ischemia and Peripheral Arterial Disease, run by CryoLife, Inc. at 7 sites in United States.
Trial summary
The objective Study is to evaluate the short- and long-term clinical outcomes of patients receiving the CryoVein cryopreserved saphenous vein allograft (CVA) as their primary open bypass conduit to assess if there is a quantifiable correlation to time of placement as a primary bypass graft and improved long-term… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia, Peripheral Arterial Disease
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2013to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with Rutherford Class 5 or 6 CLI that are being evaluated for open peripheral arterial revascularization.
Who may be able to join
- Patient is an acceptable candidate to receive primary open bypass on the limb receiving the CVA.
- CLI diagnosis of Rutherford Class 5 or 6.
- Tibio-peroneal trunk, Tibial or Peroneal outflow artery.
- Minimum of 1 patent run-off artery.
- Serum Creatinine < 2.4 mg/dl.
- Life expectancy > 2 years from consent.
Show all 11Show fewer
- 18 years of age or older at the time of consent.
- Male or non-pregnant female.
- Ability to understand and provide written informed consent.
- Willing and able to attend and cooperate with the follow-up examinations.
- Able to follow Study required post-operative daily aspirin and/or other oral anticoagulation/antiplatelet regimen.
Who cannot join
- Patient currently receiving hemodialysis for end stage renal disease.
- Known hypercoaguable state.
- Known heparin allergy.
- Patients with any condition which, in the opinion of the investigator could preclude evaluation of response or completion of follow-up or affect patient safety.
- Currently being treated with an investigational device or drug (within 3 months prior to surgery).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Texas Medical Branch
Galveston, Texas, 77555-0737
Veteran's Administration
Palo Alto, California, 94304
Sacred Heart Hospital
Pensacola, Florida, 32513
Arizona Heart Institue
Phoenix, Arizona, 85006
University of California at San Francisco
San Francisco, California, 94143-0222
Scott & White Memorial Hospital
Temple, Texas, 76508
Carle Foundation Hospital
Urbana, Illinois, 61801
About this study
Official title: Prospective, Multicenter, Primary Below the Knee Bypass Evaluation With CryoVein® Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia
The objective Study is to evaluate the short- and long-term clinical outcomes of patients receiving the CryoVein cryopreserved saphenous vein allograft (CVA) as their primary open bypass conduit to assess if there is a quantifiable correlation to time of placement as a primary bypass graft and improved long-term clinical outcomes of patients with critical limb ischemia (CLI).
Read the detailed description
A minimum of 50 CVA will be implanted in enrolled patients at up to 6 participating sites. The Study will include prospective evaluations on these patients at discharge, 1, 3, 6, 9, 12, 18 and 24 months following surgery. The window for follow-up visits is ± 2 weeks for each time point. All Study patients will be expected to participate in all follow-up evaluations unless precluded by patient death.
Patient status and graft performance data will be collected on all patients consented and enrolled into the Study. The primary endpoint of the Study will be limb salvage. The secondary endpoints of the Study will include primary patency, secondary patency, morbidity and mortality per the same reporting standards.
Patient attributes (age, gender, etc.) and preoperative assessments (indication for surgery, medical history) will be summarized using descriptive statistics. Graft performance will be presented as freedom from an event endpoint (patient death, graft complication, amputation, graft explant) as calculated by the Kaplan-Meier method. Log Rank and Cox Regression will be utilized for comparison between subgroups of the patient population. Statistical software will be used to compile and analyze all submitted clinical data.
The method of data reporting may include, but is not limited to, a description of the sample population, frequency distributions of patient demographics, allograft statistics, and follow-up percentages, summary of event data, correlation analysis, and actuarial analysis
- Keywords
- allograft, limb salvage, patency, Cryopreserved, open bypass
- Medical subject headings
- Chronic Limb-Threatening Ischemia, 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 |
|---|---|---|
| CLI patient's needing open bypass | Patients presenting with Rutherford Class 5 or 6 CLI that are being evaluated for open peripheral arterial revascularization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb Salvage
Patients will undergo follow-up assessment for limb salvage.
Measured: Assessed for 24 months following surgery.
Secondary outcomes (1)
Patency
Patients with functional grafts will undergo follow-up Study evaluation via Duplex Ultrasound.
Measured: Assessed until graft failure over a period of 24 months. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CryoLife, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott B Capps, MS, Study director, CryoLife, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799811
- Sponsor's protocol ID
- AVG1201.000-M
- Acronym
- LIMBSAVE
- Status last verified
- Aug 2024
- First submitted
- 22 Feb 2013
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Post market study of 361 product; not supporting any FDA approvals.
Publications
Walker PJ, Mitchell RS, McFadden PM, James DR, Mehigan JT. Early experience with cryopreserved saphenous vein allografts as a conduit for complex limb-salvage procedures. J Vasc Surg. 1993 Oct;18(4):561-8; discussion 568-9.
PubMed 8411463Shah RM, Faggioli GL, Mangione S, Harris LM, Kane J, Taheri SA, Ricotta JJ. Early results with cryopreserved saphenous vein allografts for infrainguinal bypass. J Vasc Surg. 1993 Dec;18(6):965-9; discussion 969-71. doi: 10.1067/mva.1993.50617.
PubMed 8264053Leseche G, Penna C, Bouttier S, Joubert S, Andreassian B. Femorodistal bypass using cryopreserved venous allografts for limb salvage. Ann Vasc Surg. 1997 May;11(3):230-6. doi: 10.1007/s100169900039.
PubMed 9140596Martin RS 3rd, Edwards WH, Mulherin JL Jr, Edwards WH Jr, Jenkins JM, Hoff SJ. Cryopreserved saphenous vein allografts for below-knee lower extremity revascularization. Ann Surg. 1994 Jun;219(6):664-70; discussion 670-2. doi: 10.1097/00000658-199406000-00009.
PubMed 8203975Farber A, Major K, Wagner WH, Cohen JL, Cossman DV, Lauterbach SR, Levin PM. Cryopreserved saphenous vein allografts in infrainguinal revascularization: analysis of 240 grafts. J Vasc Surg. 2003 Jul;38(1):15-21. doi: 10.1016/s0741-5214(03)00330-6.
PubMed 12844083Bannazadeh M, Sarac TP, Bena J, Srivastava S, Ouriel K, Clair D. Reoperative lower extremity revascularization with cadaver vein for limb salvage. Ann Vasc Surg. 2009 Jan-Feb;23(1):24-31. doi: 10.1016/j.avsg.2008.04.011. Epub 2008 Jul 26.
PubMed 18657383Buckley CJ, Abernathy S, Lee SD, Arko FR, Patterson DE, Manning LG. Suggested treatment protocol for improving patency of femoral-infrapopliteal cryopreserved saphenous vein allografts. J Vasc Surg. 2000 Oct;32(4):731-8. doi: 10.1067/mva.2000.110049.
PubMed 11013037Zehr BP, Niblick CJ, Downey H, Ladowski JS. Limb salvage with CryoVein cadaver saphenous vein allografts used for peripheral arterial bypass: role of blood compatibility. Ann Vasc Surg. 2011 Feb;25(2):177-81. doi: 10.1016/j.avsg.2010.07.020.
PubMed 20889296Randon C, Jacobs B, De Ryck F, Beele H, Vermassen F. Fifteen years of infrapopliteal arterial reconstructions with cryopreserved venous allografts for limb salvage. J Vasc Surg. 2010 Apr;51(4):869-77. doi: 10.1016/j.jvs.2009.11.062.
PubMed 20347683
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Primary Below the Knee Bypass Evaluation With CryoVein® Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT01799811
- Acronym / sponsor ID
- LIMBSAVE / AVG1201.000-M
- Keywords
- allograft, limb salvage, patency, Cryopreserved, open bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CryoLife, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Feb 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 objective Study is to evaluate the short- and long-term clinical outcomes of patients receiving the CryoVein cryopreserved saphenous vein allograft (CVA) as their primary open bypass conduit to assess if there is a quantifiable correlation to time of placement as a primary bypass graft and improved long-term clinical outcomes of patients with critical limb ischemia (CLI).
Detailed description
A minimum of 50 CVA will be implanted in enrolled patients at up to 6 participating sites. The Study will include prospective evaluations on these patients at discharge, 1, 3, 6, 9, 12, 18 and 24 months following surgery. The window for follow-up visits is ± 2 weeks for each time point. All Study patients will be expected to participate in all follow-up evaluations unless precluded by patient death.
Patient status and graft performance data will be collected on all patients consented and enrolled into the Study. The primary endpoint of the Study will be limb salvage. The secondary endpoints of the Study will include primary patency, secondary patency, morbidity and mortality per the same reporting standards.
Patient attributes (age, gender, etc.) and preoperative assessments (indication for surgery, medical history) will be summarized using descriptive statistics. Graft performance will be presented as freedom from an event endpoint (patient death, graft complication, amputation, graft explant) as calculated by the Kaplan-Meier method. Log Rank and Cox Regression will be utilized for comparison between subgroups of the patient population. Statistical software will be used to compile and analyze all submitted clinical data.
The method of data reporting may include, but is not limited to, a description of the sample population, frequency distributions of patient demographics, allograft statistics, and follow-up percentages, summary of event data, correlation analysis, and actuarial analysis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLI patient's needing open bypass | – | –Patients presenting with Rutherford Class 5 or 6 CLI that are being evaluated for open peripheral arterial revascularization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with Rutherford Class 5 or 6 CLI that are being evaluated for open peripheral arterial revascularization.
Key inclusion criteria (11 listed)
- Patient is an acceptable candidate to receive primary open bypass on the limb receiving the CVA.
- CLI diagnosis of Rutherford Class 5 or 6.
- Tibio-peroneal trunk, Tibial or Peroneal outflow artery.
- Minimum of 1 patent run-off artery.
- Serum Creatinine < 2.4 mg/dl.
Key exclusion criteria (5 listed)
- Patient currently receiving hemodialysis for end stage renal disease.
- Known hypercoaguable state.
- Known heparin allergy.
- Patients with any condition which, in the opinion of the investigator could preclude evaluation of response or completion of follow-up or affect patient safety.
- Currently being treated with an investigational device or drug (within 3 months prior to surgery).
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
Limb Salvage
Time frame: Assessed for 24 months following surgery.
Patients will undergo follow-up assessment for limb salvage.
1 secondary outcome
Patency
Time frame: Assessed until graft failure over a period of 24 months. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months".
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 19 Aug 2024.
- Background: PubMed 8411463Walker PJ, Mitchell RS, McFadden PM, James DR, Mehigan JT. Early experience with cryopreserved saphenous vein allografts as a conduit for complex limb-salvage procedures. J Vasc Surg. 1993 Oct;18(4):561-8; discussion 568-9.
- Background: PubMed 8264053Shah RM, Faggioli GL, Mangione S, Harris LM, Kane J, Taheri SA, Ricotta JJ. Early results with cryopreserved saphenous vein allografts for infrainguinal bypass. J Vasc Surg. 1993 Dec;18(6):965-9; discussion 969-71. doi: 10.1067/mva.1993.50617.
- Background: PubMed 9140596Leseche G, Penna C, Bouttier S, Joubert S, Andreassian B. Femorodistal bypass using cryopreserved venous allografts for limb salvage. Ann Vasc Surg. 1997 May;11(3):230-6. doi: 10.1007/s100169900039.
- Background: PubMed 8203975Martin RS 3rd, Edwards WH, Mulherin JL Jr, Edwards WH Jr, Jenkins JM, Hoff SJ. Cryopreserved saphenous vein allografts for below-knee lower extremity revascularization. Ann Surg. 1994 Jun;219(6):664-70; discussion 670-2. doi: 10.1097/00000658-199406000-00009.
- Background: PubMed 12844083Farber A, Major K, Wagner WH, Cohen JL, Cossman DV, Lauterbach SR, Levin PM. Cryopreserved saphenous vein allografts in infrainguinal revascularization: analysis of 240 grafts. J Vasc Surg. 2003 Jul;38(1):15-21. doi: 10.1016/s0741-5214(03)00330-6.
- Background: PubMed 18657383Bannazadeh M, Sarac TP, Bena J, Srivastava S, Ouriel K, Clair D. Reoperative lower extremity revascularization with cadaver vein for limb salvage. Ann Vasc Surg. 2009 Jan-Feb;23(1):24-31. doi: 10.1016/j.avsg.2008.04.011. Epub 2008 Jul 26.
- Background: PubMed 11013037Buckley CJ, Abernathy S, Lee SD, Arko FR, Patterson DE, Manning LG. Suggested treatment protocol for improving patency of femoral-infrapopliteal cryopreserved saphenous vein allografts. J Vasc Surg. 2000 Oct;32(4):731-8. doi: 10.1067/mva.2000.110049.
- Background: PubMed 20889296Zehr BP, Niblick CJ, Downey H, Ladowski JS. Limb salvage with CryoVein cadaver saphenous vein allografts used for peripheral arterial bypass: role of blood compatibility. Ann Vasc Surg. 2011 Feb;25(2):177-81. doi: 10.1016/j.avsg.2010.07.020.
- Background: PubMed 20347683Randon C, Jacobs B, De Ryck F, Beele H, Vermassen F. Fifteen years of infrapopliteal arterial reconstructions with cryopreserved venous allografts for limb salvage. J Vasc Surg. 2010 Apr;51(4):869-77. doi: 10.1016/j.jvs.2009.11.062.
- Individual participant dataSharing planned: No. Post market study of 361 product; not supporting any FDA approvals.
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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.
Scott B Capps, MS study director
CryoLife, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Limb Ischemia and Peripheral Arterial Disease, run by CryoLife, Inc. at 7 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 11 inclusion and 5 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 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Limb Salvage (time frame: Assessed for 24 months following surgery.). 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 NCT01799811, which also lists 9 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 19 Aug 2024.