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Coronary Artery Disease (CAD)PASSWORDNCT02554292

Post Market Surveillance of SeQuent Please Neo With Scoring Balloon

An observational study of Coronary Artery Disease (CAD), run by B. Braun Melsungen AG 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 main objective of the SeQuent® Please Neo post market surveillance is to assess the clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloon before the use of the paclitaxel-coated SeQuent® Please Neo in an 'all comer'/ 'real world' setting for the treatment of in-stent… 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?
Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation
Type of treatment
Medical device
How many people
481 participants
Where
1 siteGermany
Study dates
Oct 2015to Dec 2019
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: Patients with coronary artery disease, specifically with in-stent restenosis

Who may be able to join

  • patients with in-stent restenosis and de-novo lesions in coronary arteries

Who cannot join

  • Intolerance to paclitaxel and/or the balloon coating
  • Allergy to components of the balloon coating
  • Pregnancy and lactation
  • Complete occlusion of the treatment vessel
  • Severely calcified stenosis
  • Cardiogenic shock
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum Ernst von Bergmann

    Potsdam, 14467

Other trials in Germany

About this study

Official title: Post MArket Surveillance of SeQuent Please Neo With ScORing Balloon Lesion Preparation in Real WorlD Patients

The main objective of the SeQuent® Please Neo post market surveillance is to assess the clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloon before the use of the paclitaxel-coated SeQuent® Please Neo in an 'all comer'/ 'real world' setting for the treatment of in-stent restenosis and de-novo lesions.

Read the detailed description

The aim of this post market surveillance is to document the safety and efficacy of the drug-coated balloon Sequent® Please Neo in combination with the NSE Alpha scoring balloon in the treatment of both in-stent restenosis and de-novo lesions in native coronary arteries with reference diameters of 2.5 mm up to 4.0 mm with lesion lengths of 30 mm for procedural success and preservation of vessel patency

Being tested
Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation
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.

  • Drug Coated Balloon Angioplasty, Scoring Balloon DilatationDevice

    Also called SeQuent® Please Neo Drug Coated Balloon, NSE Alpha Scoring Balloon

    Percutaneous Coronary Intervention

What is being measured

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

  1. Target Vessel Failure

    Target Vessel Failure = TLR + Myocardial Infarction (MI) + cardiac death

    Measured: 9 months

Secondary outcomes (5)

  1. procedural success rate

    lesion crossing success in in-stent restenotic lesions

    Measured: intraprocedural

  2. Target Lesion Revascularization rate = Re-PCI + CABG(TLR)

    Measured: 9 months

  3. cardiac death

    death of cardiac or unknown causes

    Measured: 9 months

  4. Rate of coronary arterial bypass grafting (CABG)

    Measured: 9 months

  5. rate of myocardial infarction

    Measured: 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 posted18 Sep 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionDec 2018
  4. Study completionDec 2019

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
481 participants (actual)
Target duration
9 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02554292
Sponsor's protocol ID
AAG-O-A-1507
Acronym
PASSWORD
Status last verified
Mar 2020
First submitted
17 Sep 2015
Last updated
30 Mar 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Wohrle J, Zadura M, Mobius-Winkler S, Leschke M, Opitz C, Ahmed W, Barragan P, Simon JP, Cassel G, Scheller B. SeQuentPlease World Wide Registry: clinical results of SeQuent please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study. J Am Coll Cardiol. 2012 Oct 30;60(18):1733-8. doi: 10.1016/j.jacc.2012.07.040. Epub 2012 Oct 3.

    PubMed 23040575

  • Almalla M, Schroder JW, Pross V, Stegemann E, Marx N, Hoffmann R. Everolimus-eluting versus paclitaxel-eluting stents for treatment of bare metal stent restenosis. Am J Cardiol. 2011 Aug 15;108(4):518-22. doi: 10.1016/j.amjcard.2011.03.080. Epub 2011 May 31.

    PubMed 21624553

  • 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.

    PubMed 26003022

  • Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wohrle J. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol. 2012 Apr 10;59(15):1377-82. doi: 10.1016/j.jacc.2012.01.015. Epub 2012 Feb 29.

    PubMed 22386286

  • 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.

    PubMed 23206837

  • Xu B, Gao R, Wang J, Yang Y, Chen S, Liu B, Chen F, Li Z, Han Y, Fu G, Zhao Y, Ge J; PEPCAD China ISR Trial Investigators. A prospective, multicenter, randomized trial of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of drug-eluting stent in-stent restenosis: results from the PEPCAD China ISR trial. JACC Cardiovasc Interv. 2014 Feb;7(2):204-211. doi: 10.1016/j.jcin.2013.08.011.

    PubMed 24556098

  • Bonaventura K, Schwefer M, Yusof AKM, Waliszewski M, Krackhardt F, Steen P, Ocaranza R, Zuhdi AS, Bang LH, Graf K, Bock U, Chin K. Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study. Adv Ther. 2020 May;37(5):2210-2223. doi: 10.1007/s12325-020-01320-2. Epub 2020 Apr 9.

    PubMed 32274746

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 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 1 inclusion and 8 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 30 Mar 2020. 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.

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?

Target Vessel Failure (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 NCT02554292, which also lists 7 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 30 Mar 2020.

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