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AtherosclerosisECSPANDNCT02819531

Efficacy CompariSon of Pre-stenting Atherectomy Versus Scoring ballooN for calcifieD Coronary Lesions Coronary Lesions

A study testing Rotational atherectomy, Orbital atherectomy and Scoring balloon system in people with Atherosclerosis and Coronary Artery Disease, run by North Texas Veterans Healthcare System.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Design: The proposed study is a randomized study comparing the relative effectiveness of three lesion modification strategies (RA, SBS, or OAS) in the treatment of obstructive CCLs using the change in lumen size measurements (MLA, RLA, MSA and the ratio of MSA/MLA) obtained with IVUS or OCT. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atherosclerosis, Coronary Artery Disease
What is being tested?
Rotational atherectomy, Orbital atherectomy and Scoring balloon system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Jun 2016to Jun 2018
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

  • 18 years of age or older
  • Clinical indication for coronary intervention such as ischemic symptoms and/or a positive functional study
  • Found to have a de novo severe calcification (radio opacities noted without cardiac motion on contrast injection, lesion length >15 mm, or presence of >270° calcification on one cross-sectional view of IVUS) in a native coronary artery on fluoroscopy or IVUS

Who cannot join

  • Subject is currently participating in an investigational device or pharmaceutical treatment protocol
  • Persistent (>10 minutes) hypotension (systolic blood pressure <90 mmHg)
  • Need for revascularization of multiple lesions during the index PCI
  • Unprotected left main (>50%) or equivalent left main disease
  • Non-calcified lesions
  • Chronic total occlusions, extreme lesion tortuosity including Type B/C lesions
  • Severe left ventricular dysfunction (ejection fraction <25%)
  • History of bleeding diathesis or coagulopathy

About this study

Official title: A Single Center, Randomized Trial of Treatment Strategies for Obstructive Calcified Coronary Lesions: Efficacy CompariSon of Pre-stenting Atherectomy Versus Scoring ballooN for calcifieD Coronary Lesions Coronary Lesions (ECSPAND)

Design: The proposed study is a randomized study comparing the relative effectiveness of three lesion modification strategies (RA, SBS, or OAS) in the treatment of obstructive CCLs using the change in lumen size measurements (MLA, RLA, MSA and the ratio of MSA/MLA) obtained with IVUS or OCT. Patients will be blinded to treatment assignment for the duration of the study.

Treatment: Patients who are randomized to RA will undergo coronary wiring of the CCL and subsequent advancement of the RA burr. The RA system is performed using standard technique under intravenous infusion of heparin. The atherectomy burr size will be determined by the operator.

Read more

Patients who are randomized to OAS will undergo coronary wiring of the CCL and subsequent advancement of the OAS according to the manufacturer's guidelines.

Control: Patients who are randomized to SBS will undergo coronary wiring and balloon inflation with SBS performed by standard technique under intravenous infusion of heparin. SBS will be used according to the AngioSculpt manufacturer's guidelines.

Duration: 30 days follow-up.

The primary trial objective is to determine which of the three treatment strategies for treating calcified coronary lesions (RA, SBS, or OA) is superior for obtaining higher ratio of final in-stent minimum lumen area/reference lumen area, as determined by IVUS or OCT (primary study endpoint).

The secondary objectives are to compare the following:

  1. Difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain), as determined by IVUS or OCT (secondary endpoint)
  2. Mean final minimal stent area (MSA), as assessed by IVUS or OCT (secondary endpoint)
  3. Ratio of final in-stent minimum lumen diameter/reference lumen diameter, as determined by quantitative coronary angiography (secondary endpoint)
  4. Incidence of major adverse cardiac events (death, myocardial infarction, target vessel revascularization) during 30 days of follow-up (secondary endpoints)
  5. Procedure time, fluoroscopy time, and contrast volume (secondary endpoints)
Being tested
Rotational atherectomy, Orbital atherectomy, Scoring balloon system
Keywords
Coronary Atherectomy, percutaneous coronary intervention
Medical subject headings
Atherosclerosis, Coronary Artery Disease

What participants receive

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

  • Rotational atherectomyDevice

    Pre-stenting lesion modification using the rotational atherectomy device using standard technique under intravenous infusion of heparin. Burr size will be selected by the operator according to vessel size. IVUS images will be obtained before lesion modification and after stenting.

  • Orbital atherectomyDevice

    Pre-stenting lesion modification using the orbital atherectomy device according the manufacturer's guidelines. IVUS images will be obtained before lesion modification and after stenting.

  • Scoring balloon systemDevice

    Pre-stenting lesion modification using the scoring balloon system according the manufacturer's guidelines. IVUS images will be obtained before lesion modification and after stenting.

Study groups in NCT02819531
Study groupRoleWhat they receive
Rotational atherectomyActive comparatorRA protocol: After IVUS protocol, patients who are randomized to RA will undergo coronary wiring of the target lesion and subsequent advancement of the RA burr. The RA system is performed using standard technique under intravenous infusion of heparin. The atherectomy burr size will be determined by the operator.
Receives: Device: Rotational atherectomy
Orbital atherectomyActive comparatorOAS protocol: After IVUS protocol, patients who are randomized to OAS will undergo coronary wiring of the target lesion and subsequent advancement of the OAS according to the manufacturer's guidelines.
Receives: Device: Orbital atherectomy
Scoring balloon systemActive comparatorSBS protocol: After IVUS protocol, patients who are randomized to SBS will undergo coronary wiring of the target lesion and balloon inflation with SBS performed by standard technique under intravenous infusion of heparin. SBS will be used according to the manufacturer's guidelines.
Receives: Device: Scoring balloon system

What is being measured

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

  1. Ratio of final in-stent minimum lumen area/reference lumen area

    IVUS measurement based determination of ratio of final in-stent minimum lumen area/reference lumen area, as determined by IVUS

    Measured: Immediately after stenting

Secondary outcomes (7)

  1. Difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain)

    IVUS measurement based determination of difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain)

    Measured: Immediately after stenting

  2. Mean final minimal stent area (MSA)

    IVUS measurement based determination of Mean final minimal stent area (MSA)

    Measured: Immediately after stenting

  3. Ratio of final in-stent minimum lumen diameter/reference lumen diameter

    Quantitative coronary angiography based determination of ratio of final in-stent minimum lumen diameter/reference lumen diameter

    Measured: Immediately after stenting

  4. Lower incidence of major adverse cardiac events (death, myocardial infarction, target vessel revascularization) during 30 days of follow-up

    Measured: 30 days

  5. Procedure time

    Measured: Immediately after the end of the interventional procedure

  6. Fluoroscopy time

    Measured: Immediately after the end of the interventional procedure

  7. Contrast volume

    Measured: Immediately after the end of the interventional procedure

Timeline

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

  1. First posted30 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJun 2018 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02819531
Sponsor's protocol ID
16-017
Acronym
ECSPAND
Status last verified
Apr 2017
First submitted
21 Jun 2016
Last updated
7 Apr 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Genereux P, Lee AC, Kim CY, Lee M, Shlofmitz R, Moses JW, Stone GW, Chambers JW. Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial). Am J Cardiol. 2015 Jun 15;115(12):1685-90. doi: 10.1016/j.amjcard.2015.03.009. Epub 2015 Mar 24.

    PubMed 25910525

  • Vaquerizo B, Serra A, Miranda F, Triano JL, Sierra G, Delgado G, Puentes A, Mojal S, Brugera J. Aggressive plaque modification with rotational atherectomy and/or cutting balloon before drug-eluting stent implantation for the treatment of calcified coronary lesions. J Interv Cardiol. 2010 Jun;23(3):240-8. doi: 10.1111/j.1540-8183.2010.00547.x.

    PubMed 20636844

  • Adamian M, Colombo A, Briguori C, Nishida T, Marsico F, Di Mario C, Albiero R, Moussa I, Moses JW. Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with rotational atherectomy, additional stent implantation and balloon angioplasty. J Am Coll Cardiol. 2001 Sep;38(3):672-9. doi: 10.1016/s0735-1097(01)01458-9.

    PubMed 11527615

  • Genereux P, Madhavan MV, Mintz GS, Maehara A, Palmerini T, Lasalle L, Xu K, McAndrew T, Kirtane A, Lansky AJ, Brener SJ, Mehran R, Stone GW. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014 May 13;63(18):1845-54. doi: 10.1016/j.jacc.2014.01.034. Epub 2014 Feb 19.

    PubMed 24561145

Questions about this trial

What is this clinical trial studying?

A study testing Rotational atherectomy, Orbital atherectomy and Scoring balloon system in people with Atherosclerosis and Coronary Artery Disease, run by North Texas Veterans Healthcare System.

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 3 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: status not confirmed, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Ratio of final in-stent minimum lumen area/reference lumen area (time frame: Immediately after stenting). 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 NCT02819531, which also lists 4 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 7 Apr 2017.

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