NCT01083394

Brief Summary

The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

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

February 26, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 10, 2014

Status Verified

April 1, 2010

Enrollment Period

4.8 years

First QC Date

February 26, 2010

Last Update Submit

March 7, 2014

Conditions

Peripheral Vascular Disease

Keywords

PTApaclitaxelrestenosis

Outcome Measures

Primary Outcomes (1)

  • Percentage diameter stenosis

    6 months

Secondary Outcomes (5)

  • All-cause mortality

    6 and 24 months

  • Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery)

    6 Months

  • Time to onset of any of MAPE

    3-24 months

  • Binary restenosis rate

    6 months

  • Percentage diameter stenosis in duplex ultrasound

    6 and 24 months

Study Arms (2)

conventional PTA

ACTIVE COMPARATOR

In stent restenosis is treated with PTA using a conventional balloon.

Device: PTAProcedure: Percutaneous Transluminal Angioplasty (PTA)

PTA with PEB

EXPERIMENTAL

In stent restenosis is treated with PTA using a paclitaxel eluting balloon.

Device: PTA with PEBProcedure: Percutaneous Transluminal Angioplasty (PTA)

Interventions

PTADEVICE

PTA using a conventional balloon

Also known as: PACIFIC XTREME, Invatec
conventional PTA
PTA with PEBDEVICE

PTA using a paclitaxel eluting balloon

Also known as: IN.PACT PACIFIC, Invatec
PTA with PEB
Percutaneous Transluminal Angioplasty (PTA)PROCEDURE

Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon

Also known as: PACIFIC XTREME or IN.PACT PACIFIC balloons
PTA with PEBconventional PTA

Eligibility Criteria

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

You may qualify if:

  • Symptomatic ≥ 70% in-stent restenosis of the AFS, (Rutherford stage 2-6)
  • Written, informed consent by the patient or her/his legally-authorized representative for participation in the study

You may not qualify if:

  • Acute ischemia and/or acute thrombosis of the SFA
  • Untreated ipsilateral iliac artery stenosis \>70%
  • Not at least one vessel run-off
  • Popliteal involvement with stenosis \>70%
  • Severe renal insufficiency (GFR \<30 ml/min/m2)
  • Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
  • Pregnancy (present, suspected or planned) or positive pregnancy test.
  • Previous enrollment in this trial.
  • Patient's inability to fully cooperate with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

1. Medizinische Klinik, Klinikum rechts der Isar

München, Germany

RECRUITING

Deutsches Herzzentrum

München, Germany

RECRUITING

Related Publications (1)

  • Ott I, Cassese S, Groha P, Steppich B, Voll F, Hadamitzky M, Ibrahim T, Kufner S, Dewitz K, Wittmann T, Kasel AM, Laugwitz KL, Schunkert H, Kastrati A, Fusaro M. ISAR-PEBIS (Paclitaxel-Eluting Balloon Versus Conventional Balloon Angioplasty for In-Stent Restenosis of Superficial Femoral Artery): A Randomized Trial. J Am Heart Assoc. 2017 Jul 25;6(7):e006321. doi: 10.1161/JAHA.117.006321.

    PMID: 28743787DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Adnan Kastrati, MD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

  • Ilka V. Ott, MD

    Klinikum rechts der Isar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julinda Mehilli, MD

CONTACT

+49 89 12 18mehilli@dhm.mhn.de

Ilka V. Ott, MD

CONTACT

+49 89 41 40ott@dhm.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2010

First Posted

March 9, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

March 10, 2014

Record last verified: 2010-04

Locations

DE(2)