NCT01057316

Brief Summary

The purpose of the study is to evaluate the safety and effectiveness of the PTX-coating on the Formula PTX Balloon-Expandable Stent in treatment of renal artery stenosis.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
4 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2018

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

3.9 years

First QC Date

January 25, 2010

Last Update Submit

May 31, 2018

Conditions

Renal Artery Stenosis

Outcome Measures

Primary Outcomes (1)

  • Percent Diameter Stenosis of the Treated Renal Artery

    9 months

Study Arms (3)

Study Group A

EXPERIMENTAL
Device: Formula PTX Stent - Dose 1

Study Group B

EXPERIMENTAL
Device: Formula PTX Stent - Dose 2

Study Group C

EXPERIMENTAL
Device: Formula PTX Stent - Dose 3

Interventions

Formula PTX Stent - Dose 1DEVICE

Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.

Study Group A
Formula PTX Stent - Dose 2DEVICE

Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.

Study Group B
Formula PTX Stent - Dose 3DEVICE

Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.

Study Group C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • renal artery stenosis
  • appropriate size and location of the lesion

You may not qualify if:

  • pregnant or breast feeding
  • failure or inability to give informed consent
  • simultaneously participating in another drug or device study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University Hospital Ostrava

Ostrava-Poruba, 70852, Czechia

Location

Institute for Clinical and Experimental Medicine

Prague, Czechia

Location

Hopital Europeen Georges Pomidou

Paris, France

Location

Herz-Zentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Krankenhaus Neu-Bethlehem

Göttingen, 37073, Germany

Location

Uniklinik Heidelberg

Heidelberg, Germany

Location

Universitatsklinikum Leipzig AoR

Leipzig, 04103, Germany

Location

St. Bonifatius Hospital

Lingen, 49808, Germany

Location

Klinik Dr. Hancken im Elbe Klinikum Stade

Stade, 21682, Germany

Location

Royal Sussex County Hospital

Brighton, BN5BE, United Kingdom

Location

Kent & Canterbury Hospital

Canterbury, CT1 3NG, United Kingdom

Location

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Renal Artery Obstruction

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 27, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2014

Study Completion

April 9, 2018

Last Updated

June 1, 2018

Record last verified: 2018-05

Locations

CZ(2)GB(3)DE(6)FR(1)