NCT00462631

Brief Summary

The aim of the study is to compare the efficacy of Paclitaxel-eluting PTCA-balloon dilation (SeQuentTM Please) followed by cobalt-chromium stent (CoroflexTM Blue) deployment versus Paclitaxel-eluting stent (TaxusTM LibertéTM) deployment in the treatment of de-novo-stenoses in native coronary arteries (reference diameter:more then 2.5 mm and below 3.5 mm, length of stenosis ≥ 10 mm ≤ 20 mm) of patients with diabetes mellitus for ≥ 3 years for procedural success and preservation of vessel patency. This study is a prospective, randomized, multi-center, two-armed phase-II pilot study conducted in Malaysia and Thailand. 128 diabetes mellitus patients shall complete the study per protocol after random assignment to either of the treatment groups on the order of 20 to 50 patients per center. Diabetes mellitus patients with stable or selected forms of unstable angina or documented ischemia due to a de-novo stenosis in a native coronary artery will be enrolled. Vessels may not supply an entirely infarcted myocardial area. Late lumen loss at 9 months is the primary endpoint.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

April 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2007

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

4.3 years

First QC Date

April 18, 2007

Last Update Submit

February 18, 2016

Conditions

Coronary StenosisDiabetes Mellitus

Keywords

coronary arteryDiabetes

Outcome Measures

Primary Outcomes (1)

  • Late lumen loss at 9 months

    9 months

Secondary Outcomes (14)

  • Procedural success

    during procedure

  • Occurrence of acute (up to 48 hours), subacute (up to 30 days), and late thrombosis

    3 years

  • 30-day MACE rate

    30 days

  • Percent in-stent stenosis at 9 months

    9 months

  • Percent in-segment stenosis at 9 months

    9 months

  • +9 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

paclitaxel eluting balloon followed by bare metal stent

Device: Paclitaxel Eluting BalloonDevice: bare metal stent

2

ACTIVE COMPARATOR

Paclitaxel eluting stent

Device: paclitaxel eluting stent

Interventions

Paclitaxel Eluting BalloonDEVICE

Paclitaxel eluting balloon

1
paclitaxel eluting stentDEVICE

paclitaxel eluting stent

2
bare metal stentDEVICE

bare metal stent

1

Eligibility Criteria

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

You may qualify if:

  • History of diabetes mellitus of at least 3 yrs prior to enrollment. Diabetes mellitus may be treated either orally or s.c.
  • Stable blood glucose level for the 6 months preceding enrollment as reflected by HbA1c concentrations measured exclusively ≤ 8 %
  • Patients with stable angina pectoris (CCS class 1-3) or with unstable angina pectoris (Braunwald class 1-2, A-C) or documented ischemia or with documented silent ischemia
  • Patients eligible for coronary revascularization by means of PCI
  • Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 6 months follow-up
  • Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
  • Patients must agree to undergo the 9 months angiographic follow-up
  • Patients must agree to undergo the 3 year clinical follow-up
  • De-novo native coronary artery stenosis (reference diameter: ≥2.5 mm and ≤ 3.5 mm, length of stenosis: ≥ 10 mm and ≤ 20 mm)
  • Target lesion is ≥ 3 mm distant from a major side branch (\> 2.0 mm in diameter) and ≥ 3 mm form a previously deployed stent of any type (including active and passive coatings, bare metal stents)
  • The target lesion must be treated with a single stent only (multiple stenting shifts the patient to the intention-to-treat group)
  • Single or multi-vessel coronary artery disease

You may not qualify if:

  • Patients with acute (\< 24 h) or recent (48 hours) myocardial infarction
  • Patients with unstable angina pectoris (Braunwald class 3)
  • Patients with severe congestive heart failure
  • Patients with severe heart failure NYHA IV
  • Patients with severe valvular heart disease
  • Women who are pregnant or lactating
  • Patients with another coronary stent implanted previously into the target vessel, drug eluting stents less than 9 months and bare metal stents or stents with passive coatings less than 3 months before the PEPCAD IV DM PCI
  • Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
  • Patients who had a cerebral stroke \< 6 months prior to the procedure
  • Patient participates in other clinical trials involving any investigational device or drug
  • Untreated hyperthyroidism
  • Patient has presence or history of severe renal failure (GFR\<30ml/min) and is therefore not eligible for angiography. Patient's serum creatinine levels must be documented
  • Post transplantation of any organ or immune suppressive medication
  • Other disease to jeopardize follow-up (e.g., malignancy)
  • Addiction to any drug or to alcohol
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Department, Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

Related Publications (1)

  • Ali RM, Degenhardt R, Zambahari R, Tresukosol D, Ahmad WA, Kamar Hb, Kui-Hian S, Ong TK, bin Ismail O, bin Elis S, Udychalerm W, Ackermann H, Boxberger M, Unverdorben M. Paclitaxel-eluting balloon angioplasty and cobalt-chromium stents versus conventional angioplasty and paclitaxel-eluting stents in the treatment of native coronary artery stenoses in patients with diabetes mellitus. EuroIntervention. 2011 May;7 Suppl K:K83-92. doi: 10.4244/EIJV7SKA15.

    PMID: 22027736DERIVED

MeSH Terms

Conditions

Coronary StenosisDiabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

  • Rosli M Ali, MD

    Cardiology Department Institut Jantung Negara National Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Data Manager

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 19, 2007

Study Start

May 1, 2007

Primary Completion

September 1, 2011

Study Completion

February 1, 2016

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations

MY(1)