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Coronary Artery Disease (CAD)ISAR2000NCT02629575

Coroflex ISAR 2000 Registry

An observational study of Coronary Artery Disease (CAD), run by B. Braun Melsungen AG at 3 sites in 3 countries.

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

Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" patients with de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease (CAD)
What is being tested?
stenting with the Coroflex ISAR sirolimus-eluting stent
Type of treatment
Medical device
How many people
2,877 participants
Where
3 sitesin 3 countries
Study dates
Jan 2014to Dec 2017
How long will I take part?
9 Months
Phase
Observational
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

Study population: Unselected patients with coronary de-novo and/or restenotic lesions

Who may be able to join

  • patients suitable for percutaneous coronary intervention with proof of ischemia
  • at least 18 years of age

Who cannot join

  • Intolerance to sirolimus and/or probucol
  • Allergy to components of the coating
  • Pregnancy and lactation
  • Complete occlusion of the treatment vessel
  • Severely calcified stenosis
  • Cardiogenic shock
Show all 16Show fewer
  • Risk of an intraluminal thrombus
  • Haemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
  • Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
  • Severe allergy to contrast media
  • Lesions which are untreatable with PTCA or other interventional techniques
  • Patients with an ejection fraction of < 30 %
  • Vascular reference diameter < 2.00 mm
  • Treatment of the left stem (first section of the left coronary artery)
  • Indication for a bypass surgery
  • Contraindication for whichever accompanying medication is necessary

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Germany1 site

  • Charité University Hospital

    Berlin, 13353

Other trials in Germany

Malaysia1 site

  • Pusat Perubatan Universiti Malaya

    Kuala Lumpur, 59100

Other trials in Malaysia

Spain1 site

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, 13005

Other trials in Spain

About this study

Official title: Coroflex ISAR 2000 Postmarket Surveillance Non-Interventional Study

Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" patients with de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries

Read the detailed description

The aim of the study is to assess the safety and efficacy of elective deployment of the Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries of 2.0 mm up to 4.0 mm in diameter and up to 30 mm in length for procedural success and preservation of vessel patency.

Being tested
stenting with the Coroflex ISAR sirolimus-eluting stent
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • stenting with the Coroflex ISAR sirolimus-eluting stentDevice

    Also called Coroflex ISAR

    coronary stenting

What is being measured

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

  1. clinically driven Target Lesion Revascularization

    re-intervention of the target lesion

    Measured: 9 months

Secondary outcomes (6)

  1. Major Adverse Cardiac Events

    MACE=TLR+MI+cardiac/unknown death

    Measured: 9 months

  2. Myocardial infarction rate

    myocardial infarction

    Measured: 9 months

  3. Cardiac death rate

    cardiac death including death of unknown causes

    Measured: 9 months

  4. Target lesion revascularization rate

    TLR=CABG + Re-PCI

    Measured: 9 months

  5. Procedural success

    Success rate to cross and treat the coronary lesion

    Measured: immediately after stent implantation (within the first 30 minutes)

  6. Stent thrombosis rates

    rates of acute, subacute and 9-month stent thrombosis rates

    Measured: 0-9 months

Timeline

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

  1. First posted14 Dec 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2016
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,877 participants (actual)
Target duration
9 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02629575
Sponsor's protocol ID
AAG-O-H-1408
Acronym
ISAR2000
Status last verified
Mar 2018
First submitted
7 Dec 2015
Last updated
13 Mar 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Massberg S, Byrne RA, Kastrati A, Schulz S, Pache J, Hausleiter J, Ibrahim T, Fusaro M, Ott I, Schomig A, Laugwitz KL, Mehilli J; Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus- Eluting Stents (ISAR-TEST 5) Investigators. Polymer-free sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting versus Zotarolimus-eluting Stents (ISAR-TEST 5) trial. Circulation. 2011 Aug 2;124(5):624-32. doi: 10.1161/CIRCULATIONAHA.111.026732. Epub 2011 Jul 18.

    PubMed 21768546

  • Nuruddin AAB, Ahmad WAW, Waliszewski M, Heang TM, Bang LH, Yusof AKM, Abidin IZ, Zuhdi AS, Krackhardt F. Impact of Coronary Stent Architecture on Clinical Outcomes: Do Minor Changes in Stent Architecture Really Matter? Cardiol Ther. 2021 Jun;10(1):175-187. doi: 10.1007/s40119-020-00204-4. Epub 2020 Dec 4.

    PubMed 33275200

  • Krackhardt F, Waliszewski MW, Kherad B, Barth C, Marcelli D. Clinical outcomes following polymer-free sirolimus-eluting stent implantations in unselected patients: A descriptive subgroup analysis in patients with renal impairment. Medicine (Baltimore). 2020 Jul 17;99(29):e21244. doi: 10.1097/MD.0000000000021244.

    PubMed 32702903

  • Krackhardt F, Waliszewski M, Kocka V, Tousek P, Janek B, Hudec M, Lozano F, Roman KG, Del Blanco BG, Mauri J, Heang TM, Ahn TH, Jeong MH, Herberger D, Tomulic V, Levy G, Sebagh L, Rischner J, Pansieri M. Real-World Dual Antiplatelet Therapy Following Polymer-Free Sirolimus-Eluting Stent Implantations to Treat Coronary Artery Disease. Cardiovasc Drugs Ther. 2020 Jun;34(3):335-344. doi: 10.1007/s10557-020-06963-5.

    PubMed 32212061

  • Krackhardt F, Kocka V, Waliszewski M, Tousek P, Janek B, Trencan M, Krajci P, Lozano F, Roman KG, Otaegui I, Del Blanco BG, Del Olmo VV, Nofrerias EF, Wachowiak L, Heang TM, Ahn TH, Jeong MH, Jung BC, Han KR, Piot C, Sebagh L, Rischner J, Pansieri M, Leschke M. Unrestricted use of polymer-free sirolimus eluting stents in routine clinical practice. Medicine (Baltimore). 2020 Feb;99(8):e19119. doi: 10.1097/MD.0000000000019119.

    PubMed 32080086

  • Krackhardt F, Waliszewski M, Wan Ahmad WA, Kocka V, Tousek P, Janek B, Trencan M, Krajci P, Lozano F, Garcia-San Roman K, Otaegui Irurueta I, Garcia Del Blanco B, Wachowiak L, Vilalta Del Olmo V, Fernandez Nofrerias E, Ho Jeong M, Jung BC, Han KR, Piot C, Sebagh L, Rischner J, Pansieri M, Leschke M, Ahn TH. Polymer-free sirolimus-eluting stent use in Europe and Asia: Ethnic differences in demographics and clinical outcomes. PLoS One. 2020 Jan 13;15(1):e0226606. doi: 10.1371/journal.pone.0226606. eCollection 2020.

    PubMed 31929543

  • Krackhardt F, Waliszewski M, Rischner J, Piot C, Pansieri M, Ruiz-Poveda FL, Boxberger M, Noutsias M, Rios XF, Kherad B. Nine-month clinical outcomes in patients with diabetes treated with polymer-free sirolimus-eluting stents and 6-month vs. 12-month dual-antiplatelet therapy (DAPT). Herz. 2019 Aug;44(5):433-439. doi: 10.1007/s00059-017-4675-x. Epub 2018 Jan 22.

    PubMed 29356832

  • Kherad B, Waliszewski M, Leschke M, Kader MA, Bang LH, Ruiz-Poveda FL, Pieske B, Krackhardt F. 9-month results of polymer-free sirolimus eluting stents in young patients compared to a septuagenarian and octogenarian all-comer population. J Interv Cardiol. 2018 Jun;31(3):338-344. doi: 10.1111/joic.12472. Epub 2017 Dec 4.

    PubMed 29205492

  • Krackhardt F, Rosli MA, Leschke M, Schneider A, Sperling C, Heang TM, Pons M, Sousa PJ, Kherad B, Waliszewski M. Propensity score matched all comers population treated with ultra-thin strut bare metal and sirolimus-probucol coated drug-eluting stents of identical stent architecture. Catheter Cardiovasc Interv. 2018 Jun;91(7):1221-1228. doi: 10.1002/ccd.27306. Epub 2017 Sep 25.

    PubMed 28944613

  • Krackhardt F, Kocka V, Waliszewski MW, Utech A, Lustermann M, Hudec M, Studencan M, Schwefer M, Yu J, Jeong MH, Ahn T, Wan Ahmad WA, Boxberger M, Schneider A, Leschke M. Polymer-free sirolimus-eluting stents in a large-scale all-comers population. Open Heart. 2017 Jun 6;4(2):e000592. doi: 10.1136/openhrt-2017-000592. eCollection 2017.

    PubMed 28761678

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease (CAD), run by B. Braun Melsungen AG at 3 sites in 3 countries.

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 2 inclusion and 16 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 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, Malaysia, Spain. 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.

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?

clinically driven Target Lesion Revascularization (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 NCT02629575, which also lists 10 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 13 Mar 2018; AzTrials last refreshed its copy on 2 Nov 2026.

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