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Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis

NCT ID: NCT00987324

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective in the treatment of restenosis after implantation of "Limus"-eluting stents, (LES).

Detailed Description

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The use of drug-eluting stents (DES) has led to a drastic reduction of restenosis rates compared to bare metal stents (BMS), but 5% to 10% of patients receiving DES are still in need of revascularization of the treated vessel. Two important families of drugs are used for stent coating: paclitaxel belonging to the taxane family, and the "limus"-family such as sirolimus, everolimus, zotarolimus, biolimus A9 and pimecrolimus.

Data regarding the optimal treatment of in-DES-restenosis is very limited. Implanting a new DES for in-DES-restenosis has been reported to be associated with re-restenosis rates as high as 43%. Several recent well published studies have shown a substantial reduction of restenosis using paclitaxel-eluting balloons (PEB) for de-novo lesions and BMS-restenotic lesions.

The objective of this randomized trial is to assess the hypothesis, that PEB are non-inferior to paclitaxel-eluting-stents (PES) for restenosis in "limus"-eluting-stents (LES), and both, PEB and PES, are superior to plain angioplasty in patients with restenosis after initial LES implantation.

Conditions

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Heart Disease Ischemia Restenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Paclitaxel-eluting stent

Paclitaxel-eluting stent (Taxus)

Group Type EXPERIMENTAL

Taxus stent

Intervention Type DEVICE

Implantation of paclitaxel-eluting stent

Plain Balloon

plain balloon angioplasty

Group Type ACTIVE_COMPARATOR

Conventional Balloon Catheter

Intervention Type DEVICE

Ryuijin, Trek

Paclitaxel-eluting balloon

SeQuent Please

Group Type EXPERIMENTAL

SeQuent Please

Intervention Type DEVICE

Dilation with SeQuent Please (paclitaxel-eluting balloon)

Interventions

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Taxus stent

Implantation of paclitaxel-eluting stent

Intervention Type DEVICE

SeQuent Please

Dilation with SeQuent Please (paclitaxel-eluting balloon)

Intervention Type DEVICE

Conventional Balloon Catheter

Ryuijin, Trek

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels.
2. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
3. In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria

1. Age \< 18 years.
2. Cardiogenic shock.
3. Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
4. Target lesion located in the left main trunk or bypass graft.
5. Target lesion located in small vessel (vessel size \< 2.0 mm).
6. 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.
7. Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min).
8. Contraindications to antiplatelet therapy, paclitaxel, stainless steel, cobalt, chrome.
9. Pregnancy (present, suspected or planned) or positive pregnancy test.
10. Previous enrollment in this trial.
11. Patient's inability to fully comply with the study protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julinda Mehilli, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Munich

Adnan Kastrati, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum

Klaus Tiroch, MD

Role: STUDY_DIRECTOR

Deutsches Herzzentrum

Locations

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1. Med. Klinik, Klinikum rechts der Isar

Munich, Bavaria, Germany

Site Status

Herz-Zentrum

Bad Krozingen, , Germany

Site Status

Deutsches Herzzentrum

Munich, , Germany

Site Status

Countries

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Germany

References

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Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1.

Reference Type BACKGROUND
PMID: 19487593 (View on PubMed)

Giacoppo D, Alvarez-Covarrubias HA, Koch T, Cassese S, Xhepa E, Kessler T, Wiebe J, Joner M, Hochholzer W, Laugwitz KL, Schunkert H, Kastrati A, Kufner S. Coronary artery restenosis treatment with plain balloon, drug-coated balloon, or drug-eluting stent: 10-year outcomes of the ISAR-DESIRE 3 trial. Eur Heart J. 2023 Apr 17;44(15):1343-1357. doi: 10.1093/eurheartj/ehad026.

Reference Type DERIVED
PMID: 36807512 (View on PubMed)

Kufner S, Cassese S, Valeskini M, Neumann FJ, Schulz-Schupke S, Hoppmann P, Fusaro M, Schunkert H, Laugwitz KL, Kastrati A, Byrne RA; ISAR-DESIRE 3 Investigators. Long-Term Efficacy and Safety of Paclitaxel-Eluting Balloon for the Treatment of Drug-Eluting Stent Restenosis: 3-Year Results of a Randomized Controlled Trial. JACC Cardiovasc Interv. 2015 Jun;8(7):877-84. doi: 10.1016/j.jcin.2015.01.031. Epub 2015 May 20.

Reference Type DERIVED
PMID: 26003022 (View on PubMed)

Byrne RA, Neumann FJ, Mehilli J, Pinieck S, Wolff B, Tiroch K, Schulz S, Fusaro M, Ott I, Ibrahim T, Hausleiter J, Valina C, Pache J, Laugwitz KL, Massberg S, Kastrati A; ISAR-DESIRE 3 investigators. Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial. Lancet. 2013 Feb 9;381(9865):461-7. doi: 10.1016/S0140-6736(12)61964-3. Epub 2012 Dec 1.

Reference Type DERIVED
PMID: 23206837 (View on PubMed)

Other Identifiers

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GE IDE NO. S02908

Identifier Type: -

Identifier Source: org_study_id