Vascular Disease, PeripheralEarly Phase 1NCT00542646
Pilot Study to Evaluate the Safety and Preliminary Efficacy of the Peritec Peritoneal Lined Stent and Delivery System
A Early Phase 1 study testing Endovascular Intervention in people with Vascular Disease, Peripheral, run by PeriTec Biosciences Ltd. at 1 site in Chile.
Trial summary
The occurrence of Peripheral Vascular Disease has been increasing which includes the large artery in the upper leg called Superficial Femoral Artery (SFA). The Peritoneal Lined Stent has been developed as a new method for treating narrowed area in the SFA. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Disease, Peripheral
- What is being tested?
- Endovascular Intervention
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteChile
- Study dates
- Nov 2006to Nov 2010
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with claudication or ischemic rest pain(Rutherford Categories 2-4)
- The angiogram will need to have been performed confirming superficial femoral artery short segment occlusion(<5cm first two patients and <10cm there on) or high grade(>50%)stenosis
- Patient has a signed and dated informed consent
- Patient has a resting ABI <0.9 or an abnormal exercise ABI if resting ABI is normal. Patients with incompressible arteries (ABI >1.2) must have TBI <0.8
- Life expectancy greater than one year
- The ability to comply with protocol follow up requirements and required testing
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- Angiographic lesion requirements assessed at time of procedure
- Lesion of the superficial femoral artery with a short segment occlusion(<5cm first two patients and <10cm there on) or high grade (>50%) stenosis
- Target lesion 1 cm below profunda/superficial femoral artery origin and 3cm above knee joint
- Angiographic evidence of a minimum of at least one tibial with continuous artery runoff to the ankle that does not require intervention
- Guidewire has successfully traversed lesion and is within the true lumen of the distal vessel, and successful placement of 9 french(Fr) sheath
Who cannot join
- Untreated iliac artery in-flow limiting lesion
- Significant proximal common femoral or superficial femoral artery disease above or below target lesion
- Any previously treated superficial femoral artery lesion
- Any previous stenting or surgery in the target vessel
- Femoral or popliteal aneurysm
- Non-Atherosclerotic disease resulting in occlusion (e.g. embolism, vasculitis,etc)
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- Serum creatinine >2.5 mg/dl
- Any previously known coagulation disorder, including hypercoagulability
- Severe medical co-morbidities or other medical condition (for example untreated coronary heart disease and congestive heart failure, severe chronic obstructive pulmonary disease, metastasis malignance, etc.)
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Pontificia Universidad Catolica de Chile
Santiago
Albrecht Kramer, MD, 562.354.3233, kramer@med.puc.cl
About this study
The occurrence of Peripheral Vascular Disease has been increasing which includes the large artery in the upper leg called Superficial Femoral Artery (SFA). The Peritoneal Lined Stent has been developed as a new method for treating narrowed area in the SFA. This research study will determine the safety and effectiveness of the Peritoneal Lined Stent in keeping th Superficial Femoral Artery open and allowing blood to flow in the leg.
- Conditions
- Vascular Disease, Peripheral
- Being tested
- Endovascular Intervention
- 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.
Endovascular InterventionProcedure or surgery
Peritoneal Lined Stent Endovascular Intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Primary patency postprocedure and technical success Safety: Composite of major procedural adverse events
Measured: 30 Days
Secondary outcomes (1)
Primary Patency Primary Assisted Patency Secondary Patency Clinical Success Major Amputations Target Vessel Revascularization Target Lesion Revascularization
Measured: 3 Months Intervals except for Target Lesion Revascularization at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startNov 2006
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vascular Disease, PeripheralStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PeriTec Biosciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Timur Sarac, MD, Study director, PeriTec Bioscience Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542646
- Sponsor's protocol ID
- PB-PLS-2005-001
- Status last verified
- Nov 2007
- First submitted
- 10 Oct 2007
- Last updated
- 28 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Carnevale K, Ouriel K, Gabriel Y, Clair D, Bena JF, Silva MB, Sarac TP. Biological coating for arterial stents: the next evolutionary change in stents. J Endovasc Ther. 2006 Apr;13(2):164-74. doi: 10.1583/05-1710R.1.
PubMed 16643070Sarac TP, Carnevale K, Smedira N, Tanquilut E, Augustinos P, Patel A, Naska T, Clair D, Ouriel K. In vivo and mechanical properties of peritoneum/fascia as a novel arterial substitute. J Vasc Surg. 2005 Mar;41(3):490-7. doi: 10.1016/j.jvs.2004.11.033.
PubMed 15838485
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Safety and Preliminary Efficacy of the Peritec Peritoneal Lined Stent and Delivery System
- ClinicalTrials.gov ID
- NCT00542646
- Acronym / sponsor ID
- PB-PLS-2005-001
- Conditions
- Vascular Disease, Peripheral
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- PeriTec Biosciences Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Nov 2010 (estimated)
- First posted
- 11 Oct 2007 (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 occurrence of Peripheral Vascular Disease has been increasing which includes the large artery in the upper leg called Superficial Femoral Artery (SFA). The Peritoneal Lined Stent has been developed as a new method for treating narrowed area in the SFA. This research study will determine the safety and effectiveness of the Peritoneal Lined Stent in keeping th Superficial Femoral Artery open and allowing blood to flow in the leg.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patient with claudication or ischemic rest pain(Rutherford Categories 2-4)
- The angiogram will need to have been performed confirming superficial femoral artery short segment occlusion(<5cm first two patients and <10cm there on) or high grade(>50%)stenosis
- Patient has a signed and dated informed consent
- Patient has a resting ABI <0.9 or an abnormal exercise ABI if resting ABI is normal. Patients with incompressible arteries (ABI >1.2) must have TBI <0.8
- Life expectancy greater than one year
Key exclusion criteria (9 listed)
- Untreated iliac artery in-flow limiting lesion
- Significant proximal common femoral or superficial femoral artery disease above or below target lesion
- Any previously treated superficial femoral artery lesion
- Any previous stenting or surgery in the target vessel
- Femoral or popliteal aneurysm
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 |
|---|---|---|
| Endovascular InterventionPeritoneal Lined Stent Endovascular Intervention | Procedure or surgery | – |
Primary outcome
Efficacy: Primary patency postprocedure and technical success Safety: Composite of major procedural adverse events
Time frame: 30 Days
1 secondary outcome
Primary Patency Primary Assisted Patency Secondary Patency Clinical Success Major Amputations Target Vessel Revascularization Target Lesion Revascularization
Time frame: 3 Months Intervals except for Target Lesion Revascularization at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2007.
- Background: PubMed 16643070Carnevale K, Ouriel K, Gabriel Y, Clair D, Bena JF, Silva MB, Sarac TP. Biological coating for arterial stents: the next evolutionary change in stents. J Endovasc Ther. 2006 Apr;13(2):164-74. doi: 10.1583/05-1710R.1.
- Background: PubMed 15838485Sarac TP, Carnevale K, Smedira N, Tanquilut E, Augustinos P, Patel A, Naska T, Clair D, Ouriel K. In vivo and mechanical properties of peritoneum/fascia as a novel arterial substitute. J Vasc Surg. 2005 Mar;41(3):490-7. doi: 10.1016/j.jvs.2004.11.033.
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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.
Timur Sarac, MD study director
PeriTec Bioscience Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Endovascular Intervention in people with Vascular Disease, Peripheral, run by PeriTec Biosciences Ltd. at 1 site in Chile.
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 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: status not confirmed, as of the sponsor's last update on 28 Nov 2007. 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 Chile. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rajesh Khosla, MBA (216.444.1293, rkhosla@peritecbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Primary patency postprocedure and technical success Safety: Composite of major procedural adverse events (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 NCT00542646, which also lists 2 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 28 Nov 2007.