Peripheral Artery DiseasePhase 1/2TRIUMPHNCT01099215
Study of PVS-10200 for the Treatment of Restenosis in Patients With Peripheral Artery Disease (TRIUMPH)
A Phase 1/2 study testing PVS-10200 in people with Peripheral Artery Disease, run by Shire at 3 sites in France.
Trial summary
The purpose of this study is to evaluate the safety of two doses of PVS-10200, an allogeneic cellular therapy, delivered as a single injection following percutaneous transluminal ("balloon") angioplasty and stent placement for the treatment of peripheral artery disease (PAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- PVS-10200
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesFrance
- Study dates
- 30 Apr 2010to 31 Oct 2012
- Phase
- Phase 1/2
- 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 subject has signed the informed consent document and patient information leaflet.
- Male and female subject ≥ 18 years of age at the time of consent.
- If female, the subject is (a) at least 1 year post-menopausal, or (b) surgically sterile, or (c) of child-bearing potential, with a negative serum pregnancy test result prior to study enrollment, who agrees to use adequate contraception for 6 months. Adequate contraception is defined as abstinence or a reliable method of birth control (e.g., a hormonal contraceptive, intra-uterine device, implantable or injectable contraceptives (Norplant® or Depo-Provera®), diaphragm, or condom with spermicide).
- Subject has symptomatic peripheral arterial disease involving the superficial femoral artery, defined as Fontaine Class IIb, III and IV.
- Meets anatomic requirements based on biplane digital subtraction angiography performed at the time of intervention including:
- Stenosis of ≥ 50% or occlusion of the superficial femoral artery, and
Show all 12Show fewer
- Target lesion length of ≤ 150 mm, and
- At least one patent (< 50 % stenosis) tibioperoneal runoff vessel
- Target lesion is 7-15 cm in length.
- Subject is expected to stay in the same geographic area for at least 48 weeks.
- In the opinion of the investigator, the subject is able to understand and is willing to complete the study requirements.
- Subject is receiving a therapeutic dose of statin therapy (starting minimum of 7 days prior to intervention) and continuing for a minimum of 4 weeks post-intervention.
Who cannot join
- Subject has acute limb ischemia.
- Subject has had prior revascularization of the target lesion.
- Subject has untreated inflow disease of the ipsilateral pelvic arteries (> 50% stenosis or occlusion).
- The target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).
- Subject has an unresolved thrombus within the target vessel.
- Additional percutaneous interventional procedures (cardiac/peripheral) are planned ≤ 30 days following the study procedure.
Show all 20Show fewer
- Subject has suffered a hemorrhagic stroke ≤ 6 mo prior to the study procedure.
- Subject has a history of bleeding diatheses or coagulopathy.
- Subject is diagnosed with septicemia at the time of the study procedure.
- Subject is known to be seropositive for HIV.
- Subject has some other medical illness that may cause the subject to be non-compliant with the protocol.
- Subject has a known allergy to bovine or porcine products (i.e., heparin).
- Subject has a known allergy to collagen/gelatin products.
- Subject has had a severe reaction to contrast media.
- Subject has a known allergy or intolerance to anti-platelet medication (e.g., acetylsalicylic acid or clopidogrel) or statin therapy.
- Subject has a history of IV drug use within 6 months prior to screening.
- Subject has a documented diagnosis of cancer within 2 years (24 months) prior to screening.
- Subject is a female who is pregnant, breast-feeding, or plans to become pregnant during the study.
- Subject is currently participating in another investigational drug, biologic or device trial, plans to participate in another investigational drug, biologic or device study during participation in this study, or has completed participation in another investigational drug, biologic or device trial within the last 30 days. Note: Subjects involved in extended follow-up trials for products that are currently commercially available and used as approved are not considered to be participating investigational trials.
- Subject is a staff member of any of the participating institutions or relative of a staff member.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier Universitaire d'Amiens
Amiens
Hopital Europeen Georges Pompidou
Paris, 75015
Hopital Bichat
Paris, 75018
About this study
Official title: An Open-Label Dose Escalation Safety Study of PVS-10200 for the Treatment of Restenosis in Patients Undergoing Minimally Invasive Peripheral Revascularization (TRIUMPH)
The purpose of this study is to evaluate the safety of two doses of PVS-10200, an allogeneic cellular therapy, delivered as a single injection following percutaneous transluminal ("balloon") angioplasty and stent placement for the treatment of peripheral artery disease (PAD).
Read the detailed description
This is an open-label dose escalation safety study of PVS-10200 in 30 subjects with peripheral artery disease (PAD) requiring balloon angioplasty and stent placement in the superficial femoral artery (SFA). The study will be completed sequentially in two dose cohorts of 10 subjects (low dose group, Cohort A) and 20 subjects (high dose group, Cohort B). A Data Safety Monitoring Board (DSMB) will conduct regular safety reviews.
Each subject will receive one treatment of PVS-10200 delivered by ultrasound guided injection to the perivascular region (external to the vessel) of the stented target lesion. The treatment will be administered within 24 hours after balloon angioplasty/stent placement.
- Conditions
- Peripheral Artery Disease
- Being tested
- PVS-10200
- Keywords
- peripheral artery disease, percutaneous transluminal angioplasty, stent, balloon/stent, superficial femoral artery
- 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.
PVS-10200Biological
PVS-10200 is composed of allogeneic human aortic endothelial cells cultured in a gelatin matrix.
| Study group | Role | What they receive |
|---|---|---|
| PVS-10200 | Other | Each subject will receive one treatment of PVS-10200 delivered by ultrasound guided injection perivascular to the region of the target lesion within 24 hours of the completed angioplasty and stent placement. Receives: Biological: PVS-10200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Events (MAEs)
Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events
Measured: within 4 weeks after study procedure
Secondary outcomes (15)
Incidence of Major Adverse Events (MAEs)
Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events
Measured: within 24 and 48 weeks from study procedure
Incidence of Serious Adverse Events
Measured: Up to 48 weeks from study procedure
Incidence of Adverse Events, Laboratory Abnormalities
Measured: Up to 48 weeks from study procedure
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Measured: within 4 weeks from study procedure
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Measured: within 24 weeks from study procedure
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Measured: within 48 weeks from study procedure
Rate of Binary In-stent Restenosis
Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0-49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50-99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis. Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Measured: within 4 weeks from study procedure
Rate of Binary In-stent Restenosis
Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0-49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50-99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis. Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Measured: within 24 weeks from study procedure
Rate of Binary In-stent Restenosis
Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0-49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50-99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis. Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Measured: within 48 weeks from study procedure
Number of Patients Requiring Reintervention of Target Lesion / Target Vessel
Survival analysis - outcome reported as patients requiring reintervention of the target lesion / vessel
Measured: up to 48 Weeks from study procedure
Resting Ankle-brachial Index
ABI was calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. This test is used to predict the severity of PAD.
Measured: within 4, 24 and 48 weeks from study procedure
Changes in Physical Exam
Changes in physical examination were compared to baseline: numbers of subjects presenting any new finding or worsening of abnormal findings compared to the screening examination are reported
Measured: within 4, 24 and 48 weeks from baseline
The Fontaine Class of Peripheral Artery Disease
CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate -severe claudication III Ischemic rest pain IV Ulceration or gangrene
Measured: change from baseline to 4 weeks
The Fontaine Class of Peripheral Artery Disease
CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate -severe claudication III Ischemic rest pain IV Ulceration or gangrene
Measured: change from baseline to 24 weeks
The Fontaine Class of Peripheral Artery Disease
CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate -severe claudication III Ischemic rest pain IV Ulceration or gangrene
Measured: change from baseline to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2010 (estimated)
- Study start30 Apr 2010
- Primary completion30 Jun 2012
- Study completion31 Oct 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099215
- Sponsor's protocol ID
- PVS 03-001
- Other IDs
- 2009-011998-32, 2009
- Acronym
- TRIUMPH
- Status last verified
- Jun 2021
- First submitted
- 1 Apr 2010
- Last updated
- 28 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sevestre MA, Larghero J, Castier Y, Nugent HM, Visonneau S, Alsac JM. Pilot safety study of perivascular injection of tissue-engineered allogeneic aortic endothelial cells in patients undergoing minimally invasive peripheral revascularization. J Vasc Surg. 2014 Jun;59(6):1597-606. doi: 10.1016/j.jvs.2014.01.014. Epub 2014 Mar 7.
PubMed 24613691
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Dose Escalation Safety Study of PVS-10200 for the Treatment of Restenosis in Patients Undergoing Minimally Invasive Peripheral Revascularization (TRIUMPH)
- ClinicalTrials.gov ID
- NCT01099215
- Acronym / sponsor ID
- TRIUMPH / PVS 03-001
- Conditions
- Peripheral Artery Disease
- Keywords
- peripheral artery disease, percutaneous transluminal angioplasty, stent, balloon/stent, superficial femoral artery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2010 (actual)
- Primary completion
- 30 Jun 2012 (actual)
- Study completion
- 31 Oct 2012 (actual)
- First posted
- 6 Apr 2010 (estimated)
- Results
- Posted 4 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of two doses of PVS-10200, an allogeneic cellular therapy, delivered as a single injection following percutaneous transluminal ("balloon") angioplasty and stent placement for the treatment of peripheral artery disease (PAD).
Detailed description
This is an open-label dose escalation safety study of PVS-10200 in 30 subjects with peripheral artery disease (PAD) requiring balloon angioplasty and stent placement in the superficial femoral artery (SFA). The study will be completed sequentially in two dose cohorts of 10 subjects (low dose group, Cohort A) and 20 subjects (high dose group, Cohort B). A Data Safety Monitoring Board (DSMB) will conduct regular safety reviews.
Each subject will receive one treatment of PVS-10200 delivered by ultrasound guided injection to the perivascular region (external to the vessel) of the stented target lesion. The treatment will be administered within 24 hours after balloon angioplasty/stent placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PVS-10200 | Other | Biological: PVS-10200Each subject will receive one treatment of PVS-10200 delivered by ultrasound guided injection perivascular to the region of the target lesion within 24 hours of the completed angioplasty and stent placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The subject has signed the informed consent document and patient information leaflet.
- Male and female subject ≥ 18 years of age at the time of consent.
- If female, the subject is (a) at least 1 year post-menopausal, or (b) surgically sterile, or (c) of child-bearing potential, with a negative serum pregnancy test result prior to study enrollment, who agrees to use adequate contraception for 6 months. Adequate contraception is defined as abstinence or a reliable method of birth control (e.g., a hormonal contraceptive, intra-uterine device, implantable or injectable contraceptives (Norplant® or Depo-Provera®), diaphragm, or condom with spermicide).
- Subject has symptomatic peripheral arterial disease involving the superficial femoral artery, defined as Fontaine Class IIb, III and IV.
- Meets anatomic requirements based on biplane digital subtraction angiography performed at the time of intervention including:
Key exclusion criteria (20 listed)
- Subject has acute limb ischemia.
- Subject has had prior revascularization of the target lesion.
- Subject has untreated inflow disease of the ipsilateral pelvic arteries (> 50% stenosis or occlusion).
- The target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).
- Subject has an unresolved thrombus within the 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 |
|---|---|---|
| PVS-10200PVS-10200 is composed of allogeneic human aortic endothelial cells cultured in a gelatin matrix. | Biological | PVS-10200 |
Primary outcome
Incidence of Major Adverse Events (MAEs)
Time frame: within 4 weeks after study procedure
Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events
15 secondary outcomes
Incidence of Major Adverse Events (MAEs)
Time frame: within 24 and 48 weeks from study procedure
Incidence of Serious Adverse Events
Time frame: Up to 48 weeks from study procedure
Incidence of Adverse Events, Laboratory Abnormalities
Time frame: Up to 48 weeks from study procedure
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
Time frame: within 4 weeks from study procedure
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
Time frame: within 24 weeks from study procedure
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
Time frame: within 48 weeks from study procedure
Rate of Binary In-stent Restenosis
Time frame: within 4 weeks from study procedure
Rate of Binary In-stent Restenosis
Time frame: within 24 weeks from study procedure
Rate of Binary In-stent Restenosis
Time frame: within 48 weeks from study procedure
Number of Patients Requiring Reintervention of Target Lesion / Target Vessel
Time frame: up to 48 Weeks from study procedure
Resting Ankle-brachial Index
Time frame: within 4, 24 and 48 weeks from study procedure
Changes in Physical Exam
Time frame: within 4, 24 and 48 weeks from baseline
The Fontaine Class of Peripheral Artery Disease
Time frame: change from baseline to 4 weeks
The Fontaine Class of Peripheral Artery Disease
Time frame: change from baseline to 24 weeks
The Fontaine Class of Peripheral Artery Disease
Time frame: change from baseline to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24613691Sevestre MA, Larghero J, Castier Y, Nugent HM, Visonneau S, Alsac JM. Pilot safety study of perivascular injection of tissue-engineered allogeneic aortic endothelial cells in patients undergoing minimally invasive peripheral revascularization. J Vasc Surg. 2014 Jun;59(6):1597-606. doi: 10.1016/j.jvs.2014.01.014. Epub 2014 Mar 7.
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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.
Study Director study director
Takeda
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PVS-10200 in people with Peripheral Artery Disease, run by Shire at 3 sites in France.
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 12 inclusion and 20 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 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2014). 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?
Incidence of Major Adverse Events (MAEs) (time frame: within 4 weeks after study procedure). 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 NCT01099215, which also lists 1 linked publication.
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 Jun 2021.