Rapamycin-Eluting Stents With Different Polymer Coating to Reduce Restenosis (ISAR-TEST-3) - Full Text View

Purpose

The purpose of this study is to evaluate the efficacy of 3 different rapamycin-eluting-stent platforms to reduce coronary artery reblockage after stent implantation

Condition	Intervention	Phase
Coronary Heart Disease	Device: rapamycin-eluting Stent with permanent polymer Device: rapamycin-eluting stent with biodegradable polymer Device: polymer-free, rapamycin-eluting stent	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective, Randomized Trial of 3 Rapamycin-Eluting Stents With Different Polymer Coating Strategies For The Reduction of Coronary Restenosis (ISAR-TEST-3)

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:

in-stent late luminal loss [ Time Frame: at 6 to 8-month follow-up angiogram ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

In-segment binary angiographic restenosis [ Time Frame: at 6 to 8-month follow-up angiogram ] [ Designated as safety issue: No ]
Need of target lesion revascularization [ Time Frame: at 9-month follow-up ] [ Designated as safety issue: No ]
Combined incidence of death or myocardial infarction [ Time Frame: at 9-month follow-up ] [ Designated as safety issue: No ]
Incidence of stent thrombosis. [ Time Frame: at 9-month follow-up ] [ Designated as safety issue: Yes ]

Enrollment:	605
Study Start Date:	June 2006
Study Completion Date:	October 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A Drug eluting stent using biodegradable polymer BP stent	Device: rapamycin-eluting stent with biodegradable polymer due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
Active Comparator: B polymer-free drug eluting stent PF stent	Device: polymer-free, rapamycin-eluting stent due to randomization, polymer-free.rapamycin-eluting stent will be implanted
Active Comparator: C permanent polymer using stents PP stent	Device: rapamycin-eluting Stent with permanent polymer due to randomization, rapamycin-eluting stent with permanent polymer will be implanted

Detailed Description:

Coronary artery reblockage remains still a drawback of percutaneous coronary interventions even in the era of drug-eluting stents (DES). DESs working principle consists of the delivery of controlled amounts of antiproliferative agents at the local level, which results in the suppression of neointimal proliferation, the main cause of lumen re-narrowing after stent implantation. At present, several DES platforms have been developed and evaluated for clinical use. They differ between them with regard to the stent type, anti-proliferative drug, presence of polymers employed for drug storage and modification of drug-release kinetics as well as type of polymer used for this purpose. Although their mid-term efficacy has been well-established, there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with DESs. Based on animal and human pathological data, investigators have linked the above-mentioned concerns to the presence of polymers in DESs, which have a proinflammatory and prothrombinogenic potential, and sometimes may induce a hypersensitivity reaction. This trial will compare the anti-restenotic efficacy of the permanent polymer (PP), biodegradable polymer (BP) and polymer-free (PF) rapamycin-eluting stents in patients with coronary artery disease. Cypher stent (PP) is a stainless steel stent coated with sirolimus with use of permanent polymers while the ISAR stent is a rough surface stainless steel stent which allows not only polymeric coating (for example biodegradable polymer, BP ISAR stent) but also coating without the need of polymer (PF ISAR stent) in the cath lab.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% de novo stenosis located in native coronary vessels.
Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.

Exclusion Criteria:

Target lesion located in the left main trunk or bypass graft.
In-stent restenosis.
Cardiogenic shock.
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.
Known allergy to the study medications: aspirin, clopidogrel, rapamycin, stainless steel.
Pregnancy (present, suspected or planned) or positive pregnancy test.
Previous enrollment in this trial.
Patient's inability to fully cooperate with the study protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350454

Locations

Germany
1. Medizinische Klinik, Klinikum rechts der Isar
Muenchen, Germany, 81675
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Investigators

Study Chair:	Albert Schoemig, MD	Deutsches Herzzentrum Muenchen
Principal Investigator:	Adnan Kastrati, MD	Deutsches Herzzentrum Muenchen

More Information

Publications:

Sousa JE, Serruys PW, Costa MA. New frontiers in cardiology: drug-eluting stents: Part I. Circulation. 2003 May 6;107(17):2274-9. Review. No abstract available.

Babapulle MN, Joseph L, Belisle P, Brophy JM, Eisenberg MJ. A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet. 2004 Aug 14-20;364(9434):583-91.

Kastrati A, Dibra A, Eberle S, Mehilli J, Suarez de Lezo J, Goy JJ, Ulm K, Schomig A. Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials. JAMA. 2005 Aug 17;294(7):819-25.

Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005 May 4;293(17):2126-30.

McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21.

Wessely R, Kastrati A, Schomig A. Late restenosis in patients receiving a polymer-coated sirolimus-eluting stent. Ann Intern Med. 2005 Sep 6;143(5):392-4. Epub 2005 Aug 16. No abstract available.

Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004 Feb 17;109(6):701-5. Epub 2004 Jan 26.

Grube E, Sonoda S, Ikeno F, Honda Y, Kar S, Chan C, Gerckens U, Lansky AJ, Fitzgerald PJ. Six- and twelve-month results from first human experience using everolimus-eluting stents with bioabsorbable polymer. Circulation. 2004 May 11;109(18):2168-71. Epub 2004 May 3.

Hausleiter J, Kastrati A, Wessely R, Dibra A, Mehilli J, Schratzenstaller T, Graf I, Renke-Gluszko M, Behnisch B, Dirschinger J, Wintermantel E, Schomig A; investigators of the individualizable durg-eluting Stent System to Abrogate Restenosis Project. Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating. Eur Heart J. 2005 Aug;26(15):1475-81. Epub 2005 Jun 23.

Mehilli J, Kastrati A, Wessely R, Dibra A, Hausleiter J, Jaschke B, Dirschinger J, Schomig A; Intracoronary Stenting and Angiographic Restenosis--Test Equivalence Between 2 Drug-Eluting Stents (ISAR-TEST) Trial Investigators. Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss. Circulation. 2006 Jan 17;113(2):273-9. Epub 2006 Jan 3.

Wessely R, Hausleiter J, Michaelis C, Jaschke B, Vogeser M, Milz S, Behnisch B, Schratzenstaller T, Renke-Gluszko M, Stover M, Wintermantel E, Kastrati A, Schomig A. Inhibition of neointima formation by a novel drug-eluting stent system that allows for dose-adjustable, multiple, and on-site stent coating. Arterioscler Thromb Vasc Biol. 2005 Apr;25(4):748-53. Epub 2005 Jan 27. Erratum in: Arterioscler Thromb Vasc Biol. 2005 Aug;25(8):e130.

Dibra A, Kastrati A, Mehilli J, Pache J, Schuhlen H, von Beckerath N, Ulm K, Wessely R, Dirschinger J, Schomig A; ISAR-DIABETES Study Investigators. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med. 2005 Aug 18;353(7):663-70. Epub 2005 Aug 16.

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.

Responsible Party:	Prof. A. Schömig, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier:	NCT00350454 History of Changes
Other Study ID Numbers:	GE IDE No. S02306
Study First Received:	July 7, 2006
Last Updated:	January 10, 2008
Health Authority:	Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus

Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013