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CompletedNCT01099215TRIUMPHUpdated Jun 28, 2021Results posted

Study of PVS-10200 for the Treatment of Restenosis in Patients With Peripheral Artery Disease (TRIUMPH)

A Phase 1/2 interventional study of PVS-10200 in Peripheral Artery Disease, sponsored by Shire. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-28.

Sponsored by Shire · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Peripheral Artery Disease

Keywords

  • peripheral artery disease
  • percutaneous transluminal angioplasty
  • stent
  • balloon/stent
  • superficial femoral artery
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 21 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The subject has signed the informed consent document and patient information leaflet.
  2. Male and female subject ≥ 18 years of age at the time of consent.
  3. 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).
  4. Subject has symptomatic peripheral arterial disease involving the superficial femoral artery, defined as Fontaine Class IIb, III and IV.

  5. 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
    • Target lesion length of ≤ 150 mm, and
    • At least one patent (\< 50 % stenosis) tibioperoneal runoff vessel
  6. Target lesion is 7-15 cm in length.
  7. Subject is expected to stay in the same geographic area for at least 48 weeks.
  8. In the opinion of the investigator, the subject is able to understand and is willing to complete the study requirements.
  9. 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.

Exclusion criteria

Exclusion Criteria:

  1. Subject has acute limb ischemia.
  2. Subject has had prior revascularization of the target lesion.
  3. Subject has untreated inflow disease of the ipsilateral pelvic arteries (> 50% stenosis or occlusion).
  4. 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).
  5. Subject has an unresolved thrombus within the target vessel.
  6. Additional percutaneous interventional procedures (cardiac/peripheral) are planned ≤ 30 days following the study procedure.
  7. Subject has suffered a hemorrhagic stroke ≤ 6 mo prior to the study procedure.
  8. Subject has a history of bleeding diatheses or coagulopathy.
  9. Subject is diagnosed with septicemia at the time of the study procedure.
  10. Subject is known to be seropositive for HIV.
  11. Subject has some other medical illness that may cause the subject to be non-compliant with the protocol.
  12. Subject has a known allergy to bovine or porcine products (i.e., heparin).
  13. Subject has a known allergy to collagen/gelatin products.
  14. Subject has had a severe reaction to contrast media.
  15. Subject has a known allergy or intolerance to anti-platelet medication (e.g., acetylsalicylic acid or clopidogrel) or statin therapy.
  16. Subject has a history of IV drug use within 6 months prior to screening.
  17. Subject has a documented diagnosis of cancer within 2 years (24 months) prior to screening.
  18. Subject is a female who is pregnant, breast-feeding, or plans to become pregnant during the study.
  19. 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.
  20. Subject is a staff member of any of the participating institutions or relative of a staff member.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Other
    PVS-10200

    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.

    Biological: PVS-10200

Interventions

  • BiologicalPVS-10200

    PVS-10200 is composed of allogeneic human aortic endothelial cells cultured in a gelatin matrix.

06

What researchers measure

Primary outcomes

  1. Incidence of Major Adverse Events (MAEs)

    Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events

    Time frame: within 4 weeks after study procedure

Secondary outcomes

  1. Incidence of Major Adverse Events (MAEs)

    Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events

    Time frame: within 24 and 48 weeks from study procedure

  2. Incidence of Serious Adverse Events

    Time frame: Up to 48 weeks from study procedure

  3. Incidence of Adverse Events, Laboratory Abnormalities

    Time frame: Up to 48 weeks from study procedure

  4. 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.

    Time frame: within 4 weeks from study procedure

  5. 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.

    Time frame: within 24 weeks from study procedure

  6. 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.

    Time frame: within 48 weeks from study procedure

  7. 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.

    Time frame: within 4 weeks from study procedure

  8. 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.

    Time frame: within 24 weeks from study procedure

  9. 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.

    Time frame: within 48 weeks from study procedure

  10. Number of Patients Requiring Reintervention of Target Lesion / Target Vessel

    Survival analysis - outcome reported as patients requiring reintervention of the target lesion / vessel

    Time frame: up to 48 Weeks from study procedure

  11. 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.

    Time frame: within 4, 24 and 48 weeks from study procedure

  12. 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

    Time frame: within 4, 24 and 48 weeks from baseline

  13. 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

    Time frame: change from baseline to 4 weeks

  14. 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

    Time frame: change from baseline to 24 weeks

  15. 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

    Time frame: change from baseline to 48 weeks

07

Results

Posted Feb 4, 2014
Limitations and caveats
Small patient number, no control arm

Participant flow

The study period was from 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit). A total of 30 subjects were screened for study eligibility, of whom a total of 21 subjects were registered (i.e., enrolled) and treated with PVS-10200. The study was conducted at 3 study centers in France

Participant flow — Overall Study
MilestoneLow Dose PVS-10200 (Cohort A)High Dose PVS-10200 (Cohort B)
Started1110
Completed109
Not completed11
Withdrew: Withdrawal by subject10
Withdrew: Adverse event01

Outcome measures

PrimaryIncidence of Major Adverse Events (MAEs)

Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events

Time frame:
within 4 weeks after study procedure
Reported as:
Number · participants
Incidence of Major Adverse Events (MAEs)
participantsCohort ACohort B
Incidence of Major Adverse Events (MAEs)00
SecondaryIncidence of Major Adverse Events (MAEs)

Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events

Time frame:
within 24 and 48 weeks from study procedure
Reported as:
Number · participants
Incidence of Major Adverse Events (MAEs)
participantsCohort ACohort B
Week 2400
Week 4801
SecondaryIncidence of Serious Adverse Events
Time frame:
Up to 48 weeks from study procedure
Reported as:
Number · participants
Incidence of Serious Adverse Events
participantsCohort ACohort B
Incidence of Serious Adverse Events77
SecondaryIncidence of Adverse Events, Laboratory Abnormalities
Time frame:
Up to 48 weeks from study procedure
Reported as:
Number · participants
Incidence of Adverse Events, Laboratory Abnormalities
participantsCohort ACohort B
Treatment Emergent Adverse Events1110
Clinically Significant Laboratory15
SecondaryMaintenance 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.

Time frame:
within 4 weeks from study procedure
Reported as:
Number · participants
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
participantsCohort ACohort B
NO00
YES99
SecondaryMaintenance 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.

Time frame:
within 24 weeks from study procedure
Reported as:
Number · participants
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
participantsCohort ACohort B
NO44
YES54
SecondaryMaintenance 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.

Time frame:
within 48 weeks from study procedure
Reported as:
Number · participants
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
participantsCohort ACohort B
NO33
YES43
SecondaryRate 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.

Time frame:
within 4 weeks from study procedure
Reported as:
Number · participants
Rate of Binary In-stent Restenosis
participantsCohort ACohort B
NO99
YES00
SecondaryRate 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.

Time frame:
within 24 weeks from study procedure
Reported as:
Number · participants
Rate of Binary In-stent Restenosis
participantsCohort ACohort B
NO98
YES00
SecondaryRate 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.

Time frame:
within 48 weeks from study procedure
Reported as:
Number · participants
Rate of Binary In-stent Restenosis
participantsCohort ACohort B
NO87
YES00
SecondaryNumber of Patients Requiring Reintervention of Target Lesion / Target Vessel

Survival analysis - outcome reported as patients requiring reintervention of the target lesion / vessel

Time frame:
up to 48 Weeks from study procedure
Reported as:
Number · participants
Number of Patients Requiring Reintervention of Target Lesion / Target Vessel
participantsCohort ACohort B
Number of Patients Requiring Reintervention of Target Lesion / Target Vessel4 ± 15.4%2 ± 12.6%
SecondaryResting 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.

Time frame:
within 4, 24 and 48 weeks from study procedure
Reported as:
Mean · ratio
Resting Ankle-brachial Index
ratioCohort ACohort B
Week 40.984 ± 0.1280.887 ± 0.237
Week 240.948 ± 0.1720.842 ± 0.204
Week 480.931 ± 0.1930.857 ± 0.226
SecondaryChanges 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

Time frame:
within 4, 24 and 48 weeks from baseline
Reported as:
Number · participants
Changes in Physical Exam
participantsCohort ACohort B
Week 403
Week 2451
Week 4833
SecondaryThe 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

Time frame:
change from baseline to 4 weeks
Reported as:
Number · participants
The Fontaine Class of Peripheral Artery Disease
participantsCohort ACohort B
STAGE IIB (Baseline) to STAGE I (Week 4)95
STAGE IIB (Baseline) to STAGE IIA (Week 4)11
STAGE IV (Baseline) to STAGE I (Week 4)10
STAGE IV (Baseline) to STAGE IV (Week 4)04
SecondaryThe 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

Time frame:
change from baseline to 24 weeks
Reported as:
Number · participants
The Fontaine Class of Peripheral Artery Disease
participantsCohort ACohort B
STAGE IIB (Baseline) to STAGE I (Week 24)43
STAGE IIB (Baseline) to STAGE IIA (Week 24)41
STAGE IIB (Baseline) to STAGE IIB (Week 24)21
STAGE IV (Baseline) to STAGE I (Week 24)01
STAGE IV (Baseline) to STAGE IV (Week 24)02
Missing12
SecondaryThe 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

Time frame:
change from baseline to 48 weeks
Reported as:
Number · participants
The Fontaine Class of Peripheral Artery Disease
participantsCohort ACohort B
STAGE IIB (Baseline) to STAGE I (Week 48)64
STAGE IIB (Baseline) to STAGE IIA (Week 48)11
STAGE IIB (Baseline) to STAGE IIB (Week 48)31
STAGE IV (Baseline) to STAGE I (Week 48)01
STAGE IV (Baseline) to STAGE IIB (Week 48)01
STAGE IV (Baseline) to STAGE IV (Week 48)01
Missing11

Adverse events

Collected over 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort A—7/11 (63.6%)11/11 (100%)
Cohort B—7/10 (70%)10/10 (100%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventCohort ACohort B
INTERMITTENT CLAUDICATIONVascular disorders6/112/10
IN-STENT ARTERIAL RESTENOSISInjury, poisoning and procedural complications3/113/10
TOE AMPUTATIONSurgical and medical procedures0/112/10
ARTERIAL RESTENOSISInjury, poisoning and procedural complications2/110/10
ERYSIPELASInfections and infestations0/111/10
FEMORAL ARTERY OCCLUSIONVascular disorders0/111/10
LEG AMPUTATIONSurgical and medical procedures0/111/10
PYELONEPHRITISInfections and infestations0/111/10
WOUND NECROSISGeneral disorders0/111/10
ANGIOPLASTYSurgical and medical procedures1/110/10
Most frequent other events
Most frequent other events
EventCohort ACohort B
Intermittent ClaudicationVascular disorders6/112/10
HypertensionVascular disorders4/110/10
EcchymosisSkin and subcutaneous tissue disorders1/113/10
In-Stent Arterial RestenosisInjury, poisoning and procedural complications3/113/10
Toe AmputationSurgical and medical procedures0/112/10
Arterial RestenosisInjury, poisoning and procedural complications2/110/10
Injection Site HaemorrhageGeneral disorders2/110/10

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Cohort ACohort BTotal
Mean61.6 ± 10.1170.7 ± 7.6766.0 ± 9.96
Sex: Female, Male
Sex: Female, Male(Participants)Cohort ACohort BTotal
Female246
Male9615
Region of Enrollment
Region of Enrollment(Participants)Cohort ACohort BTotal
France111021
Resting Ankle Brachial Index, Leg with Target Lesion
Resting Ankle Brachial Index, Leg with Target Lesion(ratio)Cohort ACohort BTotal
Mean0.954 ± 0.1640.851 ± 0.2580.902 ± 0.217
Fontaine Classification
Fontaine Classification(Participants)Cohort ACohort BTotal
STAGE IIB-MODERATE TO SEVERE CLAUDICATION(<200M)10616
STAGE IV - ULCERATION OR GANGRENE145
08

Study locations

3 sites
  • Centre Hospitalier Universitaire d'Amiens
    Amiens, France
  • Hopital Europeen Georges Pompidou
    Paris, 75015, France
  • Hopital Bichat
    Paris, 75018, France
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01099215
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Apr 6, 2010
Start date
Apr 30, 2010
Primary completion
Jun 30, 2012
Completion
Oct 31, 2012
Results posted
Feb 4, 2014
Last update
Jun 28, 2021

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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