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Coronary StenosisPhase 2/3PEPCAD IVNCT00462631

Paclitaxel Eluting Balloon Versus Drug Eluting Stent in Native Coronary Artery Stenoses of Diabetic Patients

A Phase 2/3 study testing Paclitaxel Eluting Balloon, paclitaxel eluting stent and bare metal stent in people with Coronary Stenosis and Diabetes Mellitus, run by Heart Centre Rotenburg at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Stenosis, Diabetes Mellitus
What is being tested?
Paclitaxel Eluting Balloon, paclitaxel eluting stent and bare metal stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteMalaysia
Study dates
May 2007to Feb 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • Patients with any type of surgery during the week preceding the interventional procedure.
  • Therapy with anticoagulants
  • Poorly controlled diabetes mellitus as reflected by an HbA1c ≥ 8% during the six months prior to enrollment in PEPCAD IV DM
  • Patient has a history of peptic ulcer or gastric/intestinal bleeding during the past 6 months.
  • Evidence of extensive thrombosis within target vessel before the intervention
  • Side branch > 2 mm in diameter originating from the lesion
  • Stent within the same vessel less than 3 mm distant from target lesion
  • Multi-lesion percutaneous coronary intervention within one vessel (PCI of a total of two lesions one each in a different vessels is permitted)
  • Target lesion located in any type of coronary bypass (i.e., venous graft, arterial bypass) or graft/native artery connection
  • Coronary artery occlusions of any type (e.g., acute or chronic)
  • In-stent restenosis
  • In-segment restenosis of the native vessel within 4 mm adjacent to the target lesion

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Cardiology Department, Institut Jantung Negara

    Kuala Lumpur, 50400

Other trials in Malaysia

About this study

Official title: Paclitaxel-Eluting Balloon Angioplasty and Cobalt-Chromium Stents Versus Conventional Angioplasty and Paclitaxel-Eluting Stents in the Treatment of Native Coronary Artery Stenoses of Diabetic Patients

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.

Read more

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.

Being tested
Paclitaxel Eluting Balloon, paclitaxel eluting stent, bare metal stent
Keywords
coronary artery, Diabetes
Medical subject headings
Coronary Stenosis, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paclitaxel Eluting BalloonDevice

    Paclitaxel eluting balloon

  • paclitaxel eluting stentDevice

    paclitaxel eluting stent

  • bare metal stentDevice

    bare metal stent

Study groups in NCT00462631
Study groupRoleWhat they receive
1Experimentalpaclitaxel eluting balloon followed by bare metal stent
Receives: Device: Paclitaxel Eluting Balloon; Device: bare metal stent
2Active comparatorPaclitaxel eluting stent
Receives: Device: paclitaxel eluting stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Late lumen loss at 9 months

    Measured: 9 months

Secondary outcomes (14)

  1. Procedural success

    Measured: during procedure

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

    Measured: 3 years

  3. 30-day MACE rate

    Measured: 30 days

  4. Percent in-stent stenosis at 9 months

    Measured: 9 months

  5. Percent in-segment stenosis at 9 months

    Measured: 9 months

  6. In-stent late loss index at 9 months

    Measured: 9 months

  7. Angiographic binary in-stent stenosis rate at 9 months

    Measured: 9 months

  8. In-segment late loss index at 9 months

    Measured: 9 months

  9. Angiographic binary in-segment stenosis rate at 9 months

    Measured: 9 months

  10. Acute and cumulative MACE rate at 9 months

    Measured: 9 months

  11. Cumulative MACE rate after 2 years

    Measured: 2 years

  12. Indication for premature follow-up

    Measured: up to 9 months

  13. Type of recurrence (Mehran-Classification)

    Measured: 9 months

  14. Target vessel failure

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionSep 2011
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00462631
Sponsor's protocol ID
BBM-VS-55
Other IDs
PEPCAD IV/CRI/06-03/n-c
Acronym
PEPCAD IV
Status last verified
Feb 2016
First submitted
18 Apr 2007
Last updated
19 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22027736

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Paclitaxel Eluting Balloon, paclitaxel eluting stent and bare metal stent in people with Coronary Stenosis and Diabetes Mellitus, run by Heart Centre Rotenburg at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late lumen loss at 9 months (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00462631, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016; AzTrials last refreshed its copy on 7 Nov 2026.

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