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Complex Calcified Coronary LesionsPhase 4NCT00380809

Rotational Atherectomy Prior to Taxus Stent

A Phase 4 study testing Rotational Atherectomy + PES and Standard Treatment (PES without Rotational Atherectomy) in people with Complex Calcified Coronary Lesions, run by Segeberger Kliniken GmbH at 1 site in Germany.

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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Complex Calcified Coronary Lesions
What is being tested?
Rotational Atherectomy + PES and Standard Treatment (PES without Rotational Atherectomy)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteGermany
Study dates
Aug 2006to May 2011
Phase
Phase 4
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

  • 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
  • From the following angiographic criteria, lesions must fulfil all first degree criteria and at least one second-degree criterion to be eligible for inclusion.
  • First degree criteria
  • De-novo lesion in a native coronary artery
Show all 13Show fewer
  • 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)

Who cannot join

  • Myocardial infarction within 4 weeks
  • Left ventricular ejection fraction < 30%
  • Limited long term prognosis due to other conditions
  • Angiographic exclusion criteria:
  • Unprotected left main lesions
  • Coronary artery bypass graft stenoses
Show all 10Show fewer
  • In-stent restenoses
  • Chronic total occlusions
  • Target vessel thrombus
  • Target vessel dissection

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

    Bad Segeberg, 23795

Other trials in Germany

About this study

Official title: Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease. A Multicenter, Prospective, Randomized Controlled Trial.

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.

Read the detailed description

Calcification is an essential part of all atherosclerotic plaques. Its extent increases with the progression of atherosclerotic disease. Heavily calcified lesions form a particular threat to DES; both damage to the polymer coating during vigorous advancement and inadequate diffusion of the drug to the subintima through extensive calcium arcs could contribute to the ineffectiveness of DES when implanted into such lesions, or may lead to primary stent delivery or expansion failure. Rotational atherectomy can effectively ablate calcified plaques. In the DES era, data concerning rotational atherectomy are scarce. DES implantation following rotablation seems a rational combination, but is only poorly supported by controlled studies. In the present study, we are using 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. This prospective, randomized, controlled study aims at evaluating the long term effects of both strategies in this complex cohort of patients.

Being tested
Rotational Atherectomy + PES, Standard Treatment (PES without Rotational Atherectomy)

What participants receive

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

  • Rotational Atherectomy + PESProcedure or surgery

  • Standard Treatment (PES without Rotational Atherectomy)Procedure or surgery

Study groups in NCT00380809
Study groupRoleWhat they receive
Rotational Atherectomy + PESActive comparatorElective lesion preparation with rotational atherectomy priot to stent implantation
Receives: Procedure: Rotational Atherectomy + PES
Standard Treatment (PES without Rotational Atherectomy)Active comparatorStenting without prior rotational atherectomy, usually preceeded with balloon dilatation
Receives: Procedure: Standard Treatment (PES without Rotational Atherectomy)

What is being measured

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

  1. In-stent late lumen loss

    Measured: 9 months

Secondary outcomes (6)

  1. Major adverse cardiac events (MACE)

    Measured: 9 months

  2. In-segment late lumen loss

    Measured: 9 months

  3. In-segment binary restenosis

    Measured: 9 months

  4. Primary angiographic success

    Measured: Immediate

  5. Procedural duration and contrast dye amount

    Measured: Immediate

  6. Strategy success

    Measured: Immediate

Timeline

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

  1. First posted26 Sep 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionMay 2011
  4. Study completionMay 2011

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00380809
Sponsor's protocol ID
SK 106
Status last verified
Jul 2019
First submitted
25 Sep 2006
Last updated
26 Jul 2019
Results posted
No

Publications

  • 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.

    PubMed 14724301

  • 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.

    PubMed 15078803

  • 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.

    PubMed 12050336

  • 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.

    PubMed 14523139

  • 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.

    PubMed 14550694

  • 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.

    PubMed 8077533

  • 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.

    PubMed 9236427

  • 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.

    PubMed 23266232

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rotational Atherectomy + PES and Standard Treatment (PES without Rotational Atherectomy) in people with Complex Calcified Coronary Lesions, run by Segeberger Kliniken GmbH at 1 site in Germany.

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 13 inclusion and 10 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 26 Jul 2019. 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 Germany. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

In-stent late lumen loss (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 NCT00380809, which also lists 8 linked publications.

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 26 Jul 2019.

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