NCT01690572

Brief Summary

Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in diffuse small vessel disease especially of diabetic patients. High restenosis rates after balloon only procedures in small vessels occur due to negative constrictive vessel remodeling if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is not indicated. The main hypothesis of the trial is that in analogy to DCB success in peripheral arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a IN.PACT FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments after dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty (POBA) using a Sprinter LegendTM balloon in small vessel coronary artery disease. A constrictive remodelling process will be measured by optical coherence tomography (OCT) at 9 months median F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA therapy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

September 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

4.2 years

First QC Date

September 19, 2012

Last Update Submit

April 27, 2017

Conditions

Coronary DiseaseDiabetes Mellitus

Keywords

drug eluting balloonconstrictive remodeling

Outcome Measures

Primary Outcomes (1)

  • MACE-rate

    combined end-point: death, myocardial infarction and revascularisation of the target lesion

    12 months after initial treatment

Secondary Outcomes (1)

  • OCT-measurement

    during follow-up, after 9 months

Study Arms (2)

Paclitaxel coated balloon catheter

ACTIVE COMPARATOR

Paclitaxel coated balloon catheter "IN.PACT Falcon"

Device: Paclitaxel coated balloon catheter

uncoated balloon catheter

ACTIVE COMPARATOR

uncoated balloon catheter "sprinter legend"

Device: uncoated balloon catheter "sprinter legend"

Interventions

Paclitaxel coated balloon catheterDEVICE

Dilatation of the target lesion

Also known as: IN.PACT Falcon
Paclitaxel coated balloon catheter
uncoated balloon catheter "sprinter legend"DEVICE

Dilatation of the target lesion

Also known as: sprinter legend
uncoated balloon catheter

Eligibility Criteria

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

You may qualify if:

  • at least one target lesion with a stenosis severity ≥ 50% in one coronary segment with a diameter ≤ 2.5 mm
  • age \> 18 years
  • weight \> 45 kg
  • patient suitable for balloon dilatation and not suitable for elective implantation of a drug eluting stent
  • insulin-dependent or non-insulin-dependent diabetes mellitus
  • length of lesion ≥ 15 mm

You may not qualify if:

  • Life expectancy \< 12 months
  • In-Stent restenosis
  • planned coronary bypass or heart valve OP
  • ST elevation myocardial infarction within the last 72 hours
  • cardiogenic shock
  • renal impairment or liver dysfunction (creatinine \> 2.0 mg/dl, AST/ALT \> 3x of normal value
  • incompliance
  • pregnant or breastfeeding women or women who like to be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology and Angiology I, Heart Center,

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

MeSH Terms

Conditions

Coronary DiseaseDiabetes Mellitus

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Christoph Hehrlein, Prof. Dr.

    Department of Cardiology and Angiology I, Heart Center, Freiburg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Dr. med.

Study Record Dates

First Submitted

September 19, 2012

First Posted

September 21, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

DE(1)