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Aortic StenosisDIRECTIINCT04157920

Impact of Predilatation Between Self-expanding Valves

A study testing Transcatheter Aortic Valve Implantation with ACURATE NEO/TF and Transcatheter Aortic Valve Implantation with Medtronic CoreValve /Evolut R/Pro in people with Aortic Stenosis, run by National and Kapodistrian University of Athens at 1 site in Greece.

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

A Multicenter, prospective, non-randomized, trial evaluating the safety and clinical efficacy of the next-generation, self-expandable Boston Scientific ACURATE NEO/TF Transcatheter Heart Valves, implanted in patients with severe aortic stenosis and the impact of predilatation in comparison with the Medtronic CoreValve… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Stenosis
What is being tested?
Transcatheter Aortic Valve Implantation with ACURATE NEO/TF and Transcatheter Aortic Valve Implantation with Medtronic CoreValve /Evolut R/Pro
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteGreece
Study dates
17 Sep 2019to 20 Jul 2022
Phase
Interventional
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

  • Patient with severe symptomatic aortic stenosis defined by a mean aortic gradient > 40 mmHg or peak jet velocity > 4.0 m/s or an aortic valve area (AVA) < 1cm2 or AVA indexed to body surface area (BSA) of <0.6 cm2/m2
  • Patient is symptomatic (heart failure with New York Heart Association (NYHA) Functional Class > I, angina or syncope)
  • Patients are considered at high risk for mortality with conventional surgical aortic valve replacement as assessed by a Heart Team consisting of a cardiologist and surgeon or as confirmed by a logistic EuroSCORE I ≥ 20% and / or EuroSCORE II ≥ 7% STS score ≥ 8% OR
  • Over 80 years old OR
  • Over 65 years old with 1 or 2 (but not more than two) from the following criteria:
  • Liver cirrhosis (Class A or B). Pulmonary insufficiency: VMS<1 liter. Previous heart surgery (CABG, vascular surgery). Porcelain aorta. Pulmonary artery systolic pressure >60 mmHg and high risk for heart surgery. Relapsing pulmonary embolism. Right ventricular insufficiency. Thoracic wall injuries that contraindicate an open heart surgery. History of radiation therapy of the mediastinum. Connective tissue disease that contraindicates an open heart surgery. Frailty/cachexia.
Show all 11Show fewer
  • Aortic valve diameter of ≥20mm and ≤2 9mm as measured by echo.
  • Ascending aorta diameter ≤ 43 mm at the sinotubular junction.
  • Arterial aorto-iliac-femoral axis suitable for transfemoral access as assessed by conventional angiography and/or multi-detector computed tomographic angiography (access vessel diameter ≥ 6mm)
  • Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up
  • Patient has given written consent to participate in the trial

Who cannot join

  • A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin or heparin and bivalirudin, ticlodipine and clopidogrel, nitinol (titanium or nickel), contrast media
  • Ongoing sepsis, including active endocarditis.
  • Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to Heart Team assessment.
  • Echocardiographic evidence of LV or LA thrombus.
  • Mitral or tricuspid valve insufficiency (> grade II).
  • Previous aortic valve replacement (mechanical or bioprosthetic).
Show all 22Show fewer
  • Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  • Patients with:
  • Femoral, iliac or aortic vascular disease (stenosis etc) that precludes the insertion of a transcatheter sheath.
  • OR Symptomatic carotid or vertebral artery disease (> 70% stenosis).
  • The patient has a bleeding diathesis, coagulopathy or denies blood transfusion.
  • Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.
  • Creatinine clearance < 20 ml/min.
  • Active gastritis or gastrointestinal ulcer.
  • Pregnancy.
  • Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%.
  • Unicuspid aortic valve.
  • Mixed aortic valve disease (aortic stenosis and aortic regurgitation> 2+).
  • Liver failure (Child-Pugh class C).
  • Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
  • Extreme aortic valve calcification and calcific asymmetry (Agatston score: grade 4 AgS>5000 AU).
  • Aortic valve area of < 0.4 cm2.

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Hippocration Hospital First Department of Cardiology, University of Athens, Medical School

    Athens, 11527

Other trials in Greece

About this study

Official title: Impact of Balloon Predilatation Between Self-expanding Valves in All Comers Undergoing TAVI

A Multicenter, prospective, non-randomized, trial evaluating the safety and clinical efficacy of the next-generation, self-expandable Boston Scientific ACURATE NEO/TF Transcatheter Heart Valves, implanted in patients with severe aortic stenosis and the impact of predilatation in comparison with the Medtronic CoreValve EvolutT R/PRO systems from the DIRECT trial.

Read the detailed description

The aim of the present prospective, multicenter, non-randomized trial is to compare the device success rate and the in-hospital and 30-day safety and echocardiographic clinical outcomes between TAVI with and without predilatation in all comers undergoing implantation of self-expanding valves. Primary endpoint will be device success rate as defined by the VARC-2 criteria. Secondary endpoints involve the composite endpoint of early safety at 30 days, according to the VARC-2 definitions, specifically all cause mortality, cardiovascular mortality, stroke, acute kidney injury, life-threatening or disabling bleeding, major vascular complication, as well as the echocardiographic outcomes and valve performance as designated by the VARC-2 definitions at 30 days. VARC-1 and VARC-3 device success rates will be estimated as well.

Study type: Observational

Estimated Enrollment: 75 patients

Allocation: Non - randomized, all comers

Primary Purpose: Treatment

Observational Model: Case-Control

Condition or disease: Aortic valve stenosis

Intervention/Treatment: Device: Boston Scientific ACURATE neoTM transfemoral TAVI system

Time Perspective: Prospective

Participating centers: Hippokration Hospital (Athens, Greece), Silesian Center for Heart Diseases (Zabrze, Poland), Athens Naval Hospital (Athens, Greece). It is possible that the number of the participating center may change.

Methods: Patients treated with the Boston Scientific ACURATE NEO/TF system will be prospectively. All patients will be followed for at least 30 days.

Conditions
Aortic Stenosis
Being tested
Transcatheter Aortic Valve Implantation with ACURATE NEO/TF, Transcatheter Aortic Valve Implantation with Medtronic CoreValve /Evolut R/Pro
Keywords
Aortic stenosis, DIRECT, ACURATE, TAVI, TAVR, transcatheter, valve
Medical subject headings
Aortic Valve Stenosis

What participants receive

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

  • Transcatheter Aortic Valve Implantation with ACURATE NEO/TFDevice

    Also called Boston Scientific ACURATE neo/TF

    Transcatheter implantation of the heart valve device ACURATE neo/TF in patients suffering from severe aortic stenosis and are candidates for this operation

  • Transcatheter Aortic Valve Implantation with Medtronic CoreValve /Evolut R/ProDevice

    Also called Medtronic CoreValve /Evolut R/Pro

    Transcatheter implantation of the heart valve device Medtronic Evolut R/Pro in patients suffering from severe aortic stenosis and are candidates for this operation

Study groups in NCT04157920
Study groupRoleWhat they receive
Patients treated with Medtronic CoreValve/ Evolut R/ProOtherTAVI patients treated with Medtronic CoreValve /Evolut R - Evolut PRO Transcatheter Heart Valves, participated in the DIRECT trial
Receives: Device: Transcatheter Aortic Valve Implantation with Medtronic CoreValve /Evolut R/Pro
Patients treated with ACURATE neo/TFActive comparatorTAVI patients treated with ACURATE neo/TF Transcatheter Heart Valve recruited prospectively.
Receives: Device: Transcatheter Aortic Valve Implantation with ACURATE NEO/TF

What is being measured

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

  1. Device success

    ACURATE NEO/TF device implantation success rates, as designated by the VARC-2 criteria

    Measured: 30 days

Secondary outcomes (9)

  1. All cause Mortality

    Death teates during the hospitalization of the patient, as designated by the VARC-2 criteria

    Measured: 30 days

  2. All stroke

    Cerebrovascular accident rates during and after the hospitalization of the patient, as designated by the VARC-2 criteria

    Measured: 30 days

  3. New pacemaker implantation

    New pacemaker implantation rates during and after the hospitalization of the patient, as designated by the VARC-2 criteria

    Measured: 30 days

  4. Major Vascular complications

    Vascular complications rates during and after the hospitalization of the patient, as designated by the VARC-2 criteria

    Measured: 30 days

  5. Echocardiographic endpoint

    Echocardiographic endpoint (Post TAVI aortic valve area in cm2)

    Measured: 30 days

  6. Post-dilatation

    Post-dilatation rates

    Measured: 30 days

  7. Major Bleeding

    Major bleeding during and after the hospitalization of the patient, as designated by the VARC-2 criteria

    Measured: 30 days

  8. Acute kidney injury stage 2 or 3

    AKI stage 2 or 3 during and after the hospitalization of the patient, as designated by the VARC-2 criteria

    Measured: 30 days

  9. Device success

    ACURATE NEO/TF device implantation success rates, as designated by the VARC-1 and VARC-3 criteria

    Measured: 30 days

Timeline

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

  1. First posted8 Nov 2019
  2. Study start17 Sep 2019
  3. Primary completion1 Apr 2021
  4. Study completion20 Jul 2022

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patients undergoing TAVR for severe aortic stenosis with two different transcatheter devices. One arm received Medtronic Evolut R/Pro. The other is receiving Boston Scientific ACURATE NEO/TF
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04157920
Sponsor's protocol ID
DIRECT II
Acronym
DIRECTII
Status last verified
Dec 2023
First submitted
30 Oct 2019
Last updated
26 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arora S, Strassle PD, Ramm CJ, Rhodes JA, Vaidya SR, Caranasos TG, Vavalle JP. Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Lower Surgical Risk Scores: A Systematic Review and Meta-Analysis of Early Outcomes. Heart Lung Circ. 2017 Aug;26(8):840-845. doi: 10.1016/j.hlc.2016.12.003. Epub 2017 Jan 24.

    PubMed 28169084

  • Adams HSL, Ashokkumar S, Newcomb A, MacIsaac AI, Whitbourn RJ, Palmer S. Contemporary review of severe aortic stenosis. Intern Med J. 2019 Mar;49(3):297-305. doi: 10.1111/imj.14071.

    PubMed 30091235

  • Saikrishnan N, Kumar G, Sawaya FJ, Lerakis S, Yoganathan AP. Accurate assessment of aortic stenosis: a review of diagnostic modalities and hemodynamics. Circulation. 2014 Jan 14;129(2):244-53. doi: 10.1161/CIRCULATIONAHA.113.002310. No abstract available.

    PubMed 24421359

  • 4. Piérard L. Transcatheter aortic valve implantation: indications. E-Journal of Cardiology Practice [Internet]. 2016 5 May 2019 [cited 2019 5 May 2019]; Volume 14 Available from: https://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-14/transcatheter-aortic-valve-implantation-indications

  • Mollmann H, Diemert P, Grube E, Baldus S, Kempfert J, Abizaid A. Symetis ACURATE TF aortic bioprosthesis. EuroIntervention. 2013 Sep 10;9 Suppl:S107-10. doi: 10.4244/EIJV9SSA22. No abstract available.

    PubMed 24025946

  • Manoharan G, Walton AS, Brecker SJ, Pasupati S, Blackman DJ, Qiao H, Meredith IT. Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1359-1367. doi: 10.1016/j.jcin.2015.05.015.

    PubMed 26315740

  • Forrest JK, Mangi AA, Popma JJ, Khabbaz K, Reardon MJ, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Saul S, Qiao H, Oh JK, Williams MR. Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap. JACC Cardiovasc Interv. 2018 Jan 22;11(2):160-168. doi: 10.1016/j.jcin.2017.10.014.

    PubMed 29348010

  • Toutouzas K, Benetos G, Voudris V, Drakopoulou M, Stathogiannis K, Latsios G, Synetos A, Antonopoulos A, Kosmas E, Iakovou I, Katsimagklis G, Mastrokostopoulos A, Moraitis S, Zeniou V, Danenberg H, Vavuranakis M, Tousoulis D. Pre-Dilatation Versus No Pre-Dilatation for Implantation of a Self-Expanding Valve in All Comers Undergoing TAVR: The DIRECT Trial. JACC Cardiovasc Interv. 2019 Apr 22;12(8):767-777. doi: 10.1016/j.jcin.2019.02.005. Epub 2019 Mar 27.

    PubMed 30928442

  • Pagnesi M, Kim WK, Conradi L, Barbanti M, Stefanini GG, Zeus T, Pilgrim T, Schofer J, Zweiker D, Testa L, Taramasso M, Hildick-Smith D, Abizaid A, Wolf A, Van Mieghem NM, Sedaghat A, Wohrle J, Khogali S, Van der Heyden JAS, Webb JG, Estevez-Loureiro R, Mylotte D, MacCarthy P, Brugaletta S, Hamm CW, Bhadra OD, Schafer U, Costa G, Tamburino C, Cannata F, Reimers B, Veulemans V, Asami M, Windecker S, Eitan A, Schmidt A, Bianchi G, Bedogni F, Saccocci M, Maisano F, Alsanjari O, Siqueira D, Jensen CJ, Naber CK, Ziviello F, Sinning JM, Seeger J, Rottbauer W, Brouwer J, Alenezi A, Wood DA, Tzalamouras V, Regueiro A, Colombo A, Latib A. Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices: A Multicenter, Retrospective, Propensity-Matched Comparison of Evolut PRO Versus Acurate neo Transcatheter Heart Valves. JACC Cardiovasc Interv. 2019 Mar 11;12(5):433-443. doi: 10.1016/j.jcin.2018.11.036.

    PubMed 30846081

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter Aortic Valve Implantation with ACURATE NEO/TF and Transcatheter Aortic Valve Implantation with Medtronic CoreValve /Evolut R/Pro in people with Aortic Stenosis, run by National and Kapodistrian University of Athens at 1 site in Greece.

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 11 inclusion and 22 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 Dec 2023. 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 Greece. 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?

Device success (time frame: 30 days). 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 NCT04157920, which also lists 9 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 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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