The SELUTION DeNovo Study

• ClinicalTrials.gov Identifier: NCT04859985
• Recruitment Status: Recruiting
• First Posted: April 26, 2021
• Last Update Posted: October 19, 2023
• Sponsor: M.A. Med Alliance S.A.
• Information provided by (Responsible Party): M.A. Med Alliance S.A.

Tracking Information

• First Submitted Date: March 23, 2021
• First Posted Date: April 26, 2021
• Last Update Posted Date: October 19, 2023
• Actual Study Start Date: May 15, 2021
• Estimated Primary Completion Date: December 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 23, 2021)

• TVF [ Time Frame: 1 year after treatment ]
  - TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR) at 1 year
• TVF [ Time Frame: 5 years after treatment ]
  - TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR)) at 5 years

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 23, 2021)

• Death or any MI [ Time Frame: 30 days after treatment ]
  Cardiac death, non-cardiac death, or any Myocardial Infarction
• CD-TVR [ Time Frame: 30 days after treatment ]
  Clinically driven - Target Vessel Revascularization
• TVF [ Time Frame: 2, 3, 4, 5 years after treatment ]
  Target Vessel Failure
• Any revascularization [ Time Frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment ]
  1. Target lesion revascularization (TLR) - any and clinically driven
  2. Target vessel revascularization (TVR) - any and clinically driven
  3. A new lesion revascularization in a target vessel
  4. Non-Target vessel revascularization
• Myocardial Infarction (MI) [ Time Frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment ]
  1. Peri-procedural MI
  2. Target-vessel MI
  3. Non-target-vessel MI
  4. MI type (1 to 5) according to the 4th universal definition
• Composite of cardiac death or target vessel MI [ Time Frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment ]
  Composite of cardiac death or target vessel Myocardial Infarction
• All-cause mortality [ Time Frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment ]
  • Cardiac mortality
  • Non-cardiac mortality
• Patient-oriented ARC-2 composite endpoint [ Time Frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment ]
  1. All-cause mortality
  2. Any stroke
  3. Any MI (includes non-target vessel territory)
  4. Any revascularization
• Site-reported stroke [ Time Frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment ]
  Site-reported stroke
• Site-reported BARC 3-5 Bleeding [ Time Frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment ]
  Site-reported BARC (Bleeding Academic Research Consortium ) 3-5 Bleeding
• Cost-effectiveness of DEB vs. DES after 12 months in selected countries [ Time Frame: 1, 2, 3, 4 and 5 years after treatment ]
  Total costs of materials used during treatment
• Cost-effectiveness of DEB vs. DES after 12 months in selected countries [ Time Frame: 1, 2, 3, 4 and 5 years after treatment ]
  Time of procedure. Total minutes from patient introducer introduction until removal
• Cost-effectiveness of DEB vs. DES after 12 months in selected countries [ Time Frame: 1, 2, 3, 4 and 5 years after treatment ]
  Total hospitalization days per procedure.
• Net clinical benefit, a combination of freedom from TVF and/or BARC 3-5 bleeding [ Time Frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment ]
  Net clinical benefit, a combination of freedom from (Target Vessel Failure) TVF and/or BARC 3-5 bleeding
• Device success [ Time Frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment ]
  Device success defined as achievement of a final residual diameter stenosis of < 30% (site-reported), using the assigned device only
• Lesion success [ Time Frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment ]
  Lesion success defined as achievement of < 30% residual stenosis (site-reported), using any PCI method
• Procedure success [ Time Frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment ]
  Procedure success defined as achievement of a final diameter stenosis of < 30% (site-reported) using any PCI method, without the occurrence of death, MI, or repeat target vessel revascularization during hospital stay

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The SELUTION DeNovo Study
• Official Title: SELUTION DeNovo - A Prospective Randomized, Multi-center, International, Single-blind, Clinical Trial Compared the Selution DEB Strategy Versus DES Strategy.
• Brief Summary: A Prospective Randomized, Multi-center, International, Single-blind, Clinical trial compared the Selution DEB strategy versus DES strategy.

Detailed Description

Randomized, multi-center, international, single-blind, clinical trial. Patients meeting eligibility criteria will be randomized 1:1 to treatment of all lesions of the identified trial target vessel(s) with either the SELUTION SLR DEB or DES.

Patients randomized to the SELUTION SLR DEB arm will receive lesion preparation according to the 3rd DCB consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, shockwave, rotational atherectomy or cutting or scoring balloon at the discretion of the operator when necessary to maximize lumen diameter). Patients with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30% or FFR < 0.8) before or after use of DEB will receive a DES but remain in the SELUTION DEB group (intention to treat analysis).

Patients randomized to the DES arm will receive treatment using any CE-marked DES, as per standard institutional practice. Patients with failure to deliver DES will be first treated by provisional DEB using the SELUTION DEB, and failing that, with any other device deemed appropriate.

Staged procedures are allowed if they are planned less than 45 days after the index procedure and are done according to the initial treatment allocation for all trial target vessels (DEB if DEB arm, DES if DES arm).

The study will test:

1. for non-inferiority of a DEB plus provisional DES treatment strategy versus a systematic DES strategy with respect to the primary endpoint of TVF at 12 months.
2. for long-term superiority at 5 years of the DEB strategy with TVF as an endpoint All Patients will be followed for clinical outcomes at 30 days, 6 months, 1 2, 3, 4 and 5 years.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomised controlled trial

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Coronary Artery Disease

Intervention

• Device: SELUTION SLR
  Patients randomized to the SELUTION SLR™ DEB arm will receive lesion preparation according to the 3rd DCB consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, shockwave, rotational atherectomy or cutting or scoring balloon at the discretion of the operator when necessary to maximize lumen diameter). Patients with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30% or FFR < 0.8) before or after use of DEB will receive a DES but remain in the SELUTION SLR™ DEB group (intention to treat analysis).
• Device: DES
  For patients randomized to the DES strategy, all target lesions should be treated with DES, but use of a SELUTION SLR™ DEB or any other device is acceptable if a DES cannot be delivered to the target lesion. For bifurcation lesions, if the side-branch requires treatment it should be treated with another DES or with POBA, at the discretion of the operator, but not with a DEB.

Study Arms

• Experimental: SELUTION SLR DEB
  Device: SELUTION SLR DEB. For patients randomized to the DEB strategy, all target lesions should be treated with DEB after appropriate lesion preparation, but provisional DES implantation is acceptable if the angiographic result is considered insufficient either after lesion preparation of after DEB treatment (poor flow, dissection type C or higher, residual stenosis > 30%). For bifurcation lesions, when both main and side- branch are considered to require treatment, a DEB should be used for both.
  Intervention: Device: SELUTION SLR
• DES
  Device: Drug Eluting Stent. For patients randomized to the DES strategy, all target lesions should be treated with DES, but use of a SELUTION SLR™ DEB or any other device is acceptable if a DES cannot be delivered to the target lesion. For bifurcation lesions, if the side-branch requires treatment it should be treated with another DES or with POBA, at the discretion of the operator, but not with a DEB.
  Intervention: Device: DES

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 23, 2021): 3326
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 1, 2029
• Estimated Primary Completion Date: December 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Subjects must meet all the following criteria to participate in the trial:

• Subject age is ≥ 18 years (or 21 according to countries legal age)
• Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure or are using a contraceptive device or drug.
• Documented angina and/or positive functional testing or unstable angina or stabilized NSTEMI presentation.
• Life expectancy >1 year
• Written informed consent by the subject or her/his legally authorized representative for participation in the study
• One or more native target vessel (LAD, LCX or RCA) is considered to require intervention and is suitable for treatment of all lesions with either DEB + provisional stenting or with DES and is identified as such.
• The number of trial target lesions is not limited, but in the operator's opinion, if the subject is randomized to the DEB arm, the likelihood of the subject requiring provisional stenting of any of the identified trial target lesions is < 30%, and if randomized to the systematic DES arm, all lesions are considered amenable to stenting.
• All target lesions: diameter between 2.0 and 5 mm, and diameter stenosis >50% and <100% with distal flow at least TIMI 2

Exclusion Criteria:

Age < 18 years (or 21 according to countries legal age)

• Subject is pregnant or breast-feeding
• Definite or suspected clinically active covid-19 infection
• Subject is under judicial protection, tutorship or curatorship (for France only)
• Subject is unable to fully comply with the study protocol
• Contraindications to dual antiplatelet therapy, sirolimus or its analogues
• Presentation with STEMI
• Presentation with NSTEMI and ongoing chest pain or hemodynamic instability
• Presentation with Killip III (pulmonary oedema) or IV (cardiogenic shock)
• Chronic NYHA class III or IV heart failure prior to index PCI
• Known LVEF < 30% prior to index PCI
• Previous PCI of a trial target vessel at any time
• Previous PCI of a non-trial target vessel within 30 days
• Trial target lesion located in the left main or any arterial or venous graft
• Trial target lesion is chronic total occlusion (CTO) or in-stent restenosis (ISR)
• Subject considered not able to tolerate at least 30 seconds of coronary occlusion for each trial target lesion
• RVD of trial target lesion > 5mm
• Planned major surgery within one month following the procedure
• Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Team SelutionDenovo; 00 41 22 363 7890; selutiondenovo@medalliance.com

• Listed Location Countries: Austria, Czechia, Finland, France, Germany, Italy, Poland, Switzerland, United Kingdom

Administrative Information

• NCT Number: NCT04859985
• Other Study ID Numbers: S2021-02
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: M.A. Med Alliance S.A.
• Original Responsible Party: Same as current
• Current Study Sponsor: M.A. Med Alliance S.A.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: M.A. Med Alliance S.A.
• Verification Date: October 2023