NCT00380809

Brief Summary

The primary purpose of this study is to evaluate the long term effects of the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an angiographically well defined group of patients with complex calcified coronary lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_4

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

Study Start

First participant enrolled

August 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2006

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

4.8 years

First QC Date

September 25, 2006

Last Update Submit

July 24, 2019

Conditions

Complex Calcified Coronary Lesions

Outcome Measures

Primary Outcomes (1)

  • In-stent late lumen loss

    9 months

Secondary Outcomes (6)

  • Major adverse cardiac events (MACE)

    9 months

  • In-segment late lumen loss

    9 months

  • In-segment binary restenosis

    9 months

  • Primary angiographic success

    Immediate

  • Procedural duration and contrast dye amount

    Immediate

  • +1 more secondary outcomes

Study Arms (2)

Rotational Atherectomy + PES

ACTIVE COMPARATOR

Elective lesion preparation with rotational atherectomy priot to stent implantation

Procedure: Rotational Atherectomy + PES

Standard Treatment (PES without Rotational Atherectomy)

ACTIVE COMPARATOR

Stenting without prior rotational atherectomy, usually preceeded with balloon dilatation

Procedure: Standard Treatment (PES without Rotational Atherectomy)

Interventions

Rotational Atherectomy + PESPROCEDURE
Rotational Atherectomy + PES
Standard Treatment (PES without Rotational Atherectomy)PROCEDURE
Standard Treatment (PES without Rotational Atherectomy)

Eligibility Criteria

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

You may qualify if:

  • Angiographically proven coronary artery disease
  • Angina II-IV° following the Canadian Cardiovascular Society Classification criteria and/or reproducible ischemia in the target area by ECG or scintigraphy
  • The patient signing an informed written consent
  • First degree criteria
  • De-novo lesion in a native coronary artery
  • Target reference vessel diameter between 2.5 and 4.0 mm by visual estimation
  • Luminal diameter reduction of 70-99% by visual estimation
  • Moderate to severe calcification of the target lesion (clearly defined)
  • Second degree criteria
  • Ostial location
  • Bifurcational lesions
  • Long lesions (≥ 15mm)

You may not qualify if:

  • Myocardial infarction within 4 weeks
  • Left ventricular ejection fraction \< 30%
  • Limited long term prognosis due to other conditions
  • Unprotected left main lesions
  • Coronary artery bypass graft stenoses
  • In-stent restenoses
  • Chronic total occlusions
  • Target vessel thrombus
  • Target vessel dissection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Related Publications (8)

  • Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004 Jan 15;350(3):221-31. doi: 10.1056/NEJMoa032441.

    PMID: 14724301BACKGROUND

  • Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial. Circulation. 2004 Apr 27;109(16):1942-7. doi: 10.1161/01.CIR.0000127110.49192.72. Epub 2004 Apr 12.

    PMID: 15078803BACKGROUND

  • Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.

    PMID: 12050336BACKGROUND

  • Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.

    PMID: 14523139BACKGROUND

  • Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G; E-SIRIUS Investigators. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet. 2003 Oct 4;362(9390):1093-9. doi: 10.1016/S0140-6736(03)14462-5.

    PMID: 14550694BACKGROUND

  • Warth DC, Leon MB, O'Neill W, Zacca N, Polissar NL, Buchbinder M. Rotational atherectomy multicenter registry: acute results, complications and 6-month angiographic follow-up in 709 patients. J Am Coll Cardiol. 1994 Sep;24(3):641-8. doi: 10.1016/0735-1097(94)90009-4.

    PMID: 8077533BACKGROUND

  • Moussa I, Di Mario C, Moses J, Reimers B, Di Francesco L, Martini G, Tobis J, Colombo A. Coronary stenting after rotational atherectomy in calcified and complex lesions. Angiographic and clinical follow-up results. Circulation. 1997 Jul 1;96(1):128-36. doi: 10.1161/01.cir.96.1.128.

    PMID: 9236427BACKGROUND

  • Abdel-Wahab M, Richardt G, Joachim Buttner H, Toelg R, Geist V, Meinertz T, Schofer J, King L, Neumann FJ, Khattab AA. High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2013 Jan;6(1):10-9. doi: 10.1016/j.jcin.2012.07.017. Epub 2012 Dec 19.

    PMID: 23266232DERIVED

MeSH Terms

Interventions

Atherectomy, Coronary

Intervention Hierarchy (Ancestors)

AtherectomyAngioplastyCatheterizationTherapeuticsMyocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeEndovascular ProceduresVascular Surgical ProceduresPercutaneous Coronary InterventionMinimally Invasive Surgical ProceduresThoracic Surgical ProceduresInvestigative Techniques

Study Officials

  • Gert Richardt, MD

    Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

    STUDY CHAIR

  • Ahmed A. Khattab, MD

    Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

    PRINCIPAL INVESTIGATOR

  • Mohamed Abdel-Wahab, MD

    Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 26, 2006

Study Start

August 1, 2006

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations

DE(1)