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

NCT00987324 | Completed Phase 4

• 1 other identifier: GE IDE NO. S02908
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Heart Disease; Ischemia; Restenosis

Outcome Measures

Primary Outcomes (1)

• Percent in-segment diameter stenosis at follow-up angiography

  6-8 months

Secondary Outcomes (4)

• In-segment minimal luminal diameter

  6-8 months

• In-segment binary angiographic restenosis

  6-8 months

• Combined incidence of death or myocardial infarction

  1 and 2 years

• Incidence of thrombosis

  1 and 2 years

Study Arms (3)

Paclitaxel-eluting stent

EXPERIMENTAL

Paclitaxel-eluting stent (Taxus)

Device: Taxus stent

Plain Balloon

ACTIVE COMPARATOR

plain balloon angioplasty

Device: Conventional Balloon Catheter

Paclitaxel-eluting balloon

EXPERIMENTAL

SeQuent Please

Device: SeQuent Please

Interventions

Taxus stent DEVICE

Implantation of paclitaxel-eluting stent

Paclitaxel-eluting stent

SeQuent Please DEVICE

Dilation with SeQuent Please (paclitaxel-eluting balloon)

Paclitaxel-eluting balloon

Conventional Balloon Catheter DEVICE

Ryuijin, Trek

Plain Balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (3)

1. Med. Klinik, Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

Location

Herz-Zentrum

Bad Krozingen, 79189, Germany

Location

Deutsches Herzzentrum

Munich, 80636, Germany

Location

Related Publications (4)

• 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.

  PMID: 19487593 BACKGROUND

• 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.

  PMID: 36807512 DERIVED

• 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.

  PMID: 26003022 DERIVED

• 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.

  PMID: 23206837 DERIVED

MeSH Terms

Conditions

Heart Diseases; Ischemia

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julinda Mehilli, MD

  Deutsches Herzzentrum Munich

  PRINCIPAL INVESTIGATOR

• Adnan Kastrati, MD

  Deutsches Herzzentrum

  STUDY CHAIR

• Klaus Tiroch, MD

  Deutsches Herzzentrum

  STUDY DIRECTOR

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: August 27, 2009
• First Posted: September 30, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2013
• Last Updated: November 21, 2016

Record last verified: 2016-11

Locations

DE (3)