Outcomes

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DES Clinical Trials

Svelte technologies deliver outstanding clinical results, enhance patient comfort and improve procedural efficiency.

Svelte technologies deliver safe and sustained clinical results. The ultra-low profile and reinforced proximal shaft of SLENDER IDS facilitates a transradial and direct stenting approach to PCI, even in complex anatomy.

Despite 50% of investigators in the DIRECT I and II clinical studies being first-time users of the IDS:

  • 98% of cases were free of device failure
  • 96% of lesions were direct stented successfully
  • 74% of patients were treated via transradial approach
  • Low late loss, including in diabetics, is observed
  • 1.9% TLR across all patients is reported through 4+ years
  • 0% death or stent thrombosis is reported in 4+ years

And as the only DES indicated for use with diagnostic and smaller catheters (0.047″ ID), SLENDER IDS offers the opportunity to downsize catheters to facilitate TRI while extracting steps from procedures – benefitting patients and saving time.

DIRECT I First-In-Man Study

Direct Implantation of a Rapamycin-Eluting Stent with Bio-Eroding Carrier Technology Using an Integrated Delivery System

Study Objective:

Assess the safety and the clinical performance of the Svelte drug-eluting coronary stent utilizing an Integrated Delivery System (IDS) in patients with de novo coronary artery lesions.

Study Design:

Prospective, non-randomized, single-arm, multi-center study of 30 patients with clinical, angiographic, IVUS and OCT follow-up at 6-Months to determine the primary endpoints of Target Vessel Failure (TVF) and Late lumen Loss (LL), as well as secondary endpoints. Additional clinical follow-up will take place at 30-days and yearly up to 5 years.

Patient Population:

Patients with symptomatic ischemic heart disease due to a single de novo stenotic lesion contained within a native coronary artery with a reference vessel diameter between 2.5 mm and 3.5 mm and lesion length < 23 mm that is amenable to revascularization with percutaneous coronary intervention (PCI) with stent deployment.

Primary Endpoint:

Safety:

Target vessel failure (TVF) at 6 months post-procedure

Efficacy:

In-stent late lumen loss (LL) at 6 months post procedure

Secondary Endpoints:

Safety:

  1. Clinically-driven target lesion revascularization (TLR) at 1 and 6 months and yearly through 5 years post-procedure;
  2. Composite of cardiac death, MI attributed to the target vessel and clinically driven TLR at 1 and 6 months post-procedure, and yearly up to 5 years;
  3. Composite of all-cause mortality, any MI and any revascularization, TVR or revascularization of non target vessels at 5 years post procedure;
  4. Stent thrombosis at 1 and 6 months and yearly for 5 years post-procedure;
  5. Successful deployment of Svelte DES with a <20% residual stenosis;
  6. Acute success rates:
    • Device Success: Attainment of <30% final residual stenosis of the target lesion using only the Svelte stent and direct stenting, without pre-dilatation or post-dilatation using a separate device;
    • Lesion Success: Attainment of <30% final residual stenosis of the target lesion using the Svelte stent and with any adjunctive devices (such as pre-dilatation and/or post-dilatation balloon or other interventional devices);
    • Procedure Success: Attainment of < 30% final residual stenosis of the target lesion and no in-hospital MACE;
    • Direct Stenting Success: Device success and no in-hospital MACE.
  7. Bleeding or vascular complications at discharge;
  8. Late stent thrombosis at 6 months

Efficacy:

  1. In-stent and in-segment angiographic binary restenosis rate at 6 months post procedure;
  2. In-stent and in-segment minimum lumen diameter at 6 months post-procedure;
  3. In-segment LL at 6-months post-procedure;
  4.  Neointimal hyperplasia (% lumen volume) at 6 months post-procedure as measured by Intravascular Ultrasound (IVUS);
  5. Strut coverage (% of struts malopposed, protruding non-covered, protruding covered, non-protruding covered) at 6-months post-procedure measured by optical coherence tomography (OCT).

Key Eligibility Criteria

  • Clinical evidence of stable or unstable angina, silent ischemia or positive functional study
  • Single target lesion or two lesions (target and non-target) located in separate coronary arteries
  • RVD ≥ 2.5 mm and ≤ 3.5 mm
  • Target lesion < 20 mm with stenosis ≥ 50% and < 100%

Study Outcomes:

  • Angiographic: 3.28 mm3 in-stent neointimal volume, 2.7% in-stent volume obstruction at 6 months
  • Clinical: 0% MACE, 0% stent thrombosis through 4 years
  • Svelte IDS feasibility clearly established

DIRECT I Study Outcomes

Study Primary Investigator: Mark Webster, MBChB

Core Lab: Cardialysis BV, Rotterdam, The Netherlands

Clinical Research Organization: PCRG, Sydney, Australia

DIRECT II Randomized Controlled Study

Direct Implantation of a Rapamycin-Eluting Stent with Bio-Eroding Carrier Technology Using an Integrated Delivery System

Study Objective:

Assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, de novo coronary artery lesions.

Study Design:

Prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting IDS to that of the commercially available Resolute Integrity Drug-Eluting Stent.  One hundred fifty-nine (159) patients (2:1 randomization Svelte IDS: Resolute Integrity to establish non-inferiority in the primary efficacy endpoint of in-stent late lumen loss) will be treated in up to twenty (20) centers in Europe and Brazil, with clinical and angiographic follow-up at 6 months to assess the primary endpoints of Target Vessel Failure (TVF) and Late Lumen Loss (LL), as well as secondary safety and efficacy endpoints.  Additional clinical follow-up will take place at 1-month and annually through 5 years.

Patient Population:

Patients with symptomatic ischemic heart disease due to a single de novo stenotic lesion contained within a native coronary artery with a reference vessel diameter between 2.5 mm and 3.5 mm and lesion length < 23 mm that is amenable to revascularization with percutaneous coronary intervention (PCI) with stent deployment.

Primary Endpoint:

Safety:

Target vessel failure (TVF) at 6 months post-procedure

Efficacy:

In-stent late lumen loss (LL) at 6 months post procedure

Secondary Endpoints:

Safety:

  1. Clinically-driven target lesion revascularization (TLR) at 1 and 6 months and yearly through 5 years post-procedure;
  2. Composite of cardiac death, MI attributed to the target vessel and clinically driven TLR at 1 and 6 months post-procedure, and yearly up to 5 years;
  3. Composite of all-cause mortality, any MI and any revascularization, TVR or revascularization of non target vessels at 5 years post procedure;
  4. Stent thrombosis at 1 and 6 months and yearly for 5 years post-procedure;
  5. Successful deployment of Svelte DES with <20% residual stenosis;
  6. Acute success rates:
    • Device Success: Attainment of <30% final residual stenosis of the target lesion using only the Svelte stent and direct stenting, without pre-dilatation or post-dilatation using a separate device;
    • Lesion Success: Attainment of <30% final residual stenosis of the target lesion using the Svelte stent and with any adjunctive devices (such as pre-dilatation and/or post-dilatation balloon or other interventional devices);
    • Procedure Success: Attainment of < 30% final residual stenosis of the target lesion and no in-hospital MACE;
    • Direct Stenting Success: Device success and no in-hospital MACE.

Efficacy:

  1. In-stent and in-segment angiographic binary restenosis rate at 6 months post procedure;
  2. In-stent and in-segment minimum lumen diameter at 6 months post-procedure;
  3. In-segment LL at 6 months post-procedure;
  4.  Neointimal hyperplasia (% lumen volume) at 6 months post-procedure as measured by Intravascular Ultrasound (IVUS);
  5. Strut coverage (% of struts malopposed, protruding non-covered, protruding covered, non-protruding covered) at 6 months post-procedure measured by optical coherence tomography (OCT).

Key Eligibility Criteria

  • Clinical evidence of stable or unstable angina, silent ischemia or positive functional study
  • Single target lesion or two lesions (target and non-target) located in separate coronary arteries
  • RVD ≥ 2.5 mm and ≤ 3.5 mm
  • Target lesion < 20 mm with stenosis ≥ 50% and < 100%

Study Outcomes:

  • Angiographic: 0.09 mm late lumen loss at 6 months (P < 0.001 for non-inferiority)
  • Clinical: 1.9% TLR, 0% stent thrombosis through 2 years (no change from 1 to 2 years)
  • Non-inferiority in 6-month late lumen loss of Svelte IDS compared wit active control clearly established (study primary endpoint met)

DIRECT II STudy Outcomes

Study Primary Investigator: Stefan Verheye, MD, PhD

Core Lab: Cardialysis BV, Rotterdam, The Netherlands

Clinical Research Organization: Genae Associates, Antwerp, Belgium

Excellent long-term outcomes were achieved in multiple clinical studies. Realize the benefits of TRI direct stenting with Svelte balloon technologies.

Achieve Exceptional Outcomes.

 DIRECT I clinical study.

 DIRECT II clinical study.

CAUTION: The law restricts SLENDER IDS to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. SLENDER IDS is CE approved. DIRECT RX is an investigational device not approved for commercial use. SLENDER IDS and DIRECT RX are not available for sale in the US.