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

NCT01099215 | Completed Phase 1 Results DMC

• 2 other identifiers: PVS 03-0012009-011998-32
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Peripheral Artery Disease

Keywords

peripheral artery disease; percutaneous transluminal angioplasty; stent; balloon/stent; superficial femoral artery

Outcome Measures

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

  within 4 weeks after study procedure

Secondary Outcomes (15)

• Incidence of Major Adverse Events (MAEs)

  within 24 and 48 weeks from study procedure

• Incidence of Serious Adverse Events

  Up to 48 weeks from study procedure

• Incidence of Adverse Events, Laboratory Abnormalities

  Up to 48 weeks from study procedure

• Maintenance of Primary Patency of Superficial Femoral Artery (SFA)

  within 4 weeks from study procedure

• Maintenance of Primary Patency of Superficial Femoral Artery (SFA)

  within 24 weeks from study procedure

Study Arms (1)

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.

Biological: PVS-10200

Interventions

PVS-10200 BIOLOGICAL

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

PVS-10200

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (3)

Centre Hospitalier Universitaire d'Amiens

Amiens, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Bichat

Paris, 75018, France

Location

Related Publications (1)

• 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.

  PMID: 24613691 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Limitations and Caveats

Small patient number, no control arm

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 6, 2010
• Study Start: April 30, 2010
• Primary Completion: June 30, 2012
• Study Completion: October 31, 2012
• Last Updated: June 28, 2021
• Results First Posted: February 4, 2014

Record last verified: 2021-06

Locations

FR (3)