Concept Medical Inc. - Best Heart Care Institute in Surat
MagicTouch - Concept Medical Inc. - Best Heart Care Institute in Surat
Clinical Data

NANOLUTE STUDY

POST MARKET CLINICAL FOLLOW UP

The Nanolute multi-centre Registry for clinical evaluation of Sirolimus Coated Balloon which enrolled real world, all comer patients from the routine clinical practice at various interventional cardiology sites in India.

This Clinical registry is conducted in compliance with the ISO: 14155 and all applicable regulatory requirements.

STUDY OBJECTIVE:

Purpose of this registry is to evaluate the safety and efficacy of Sirolimus Coated Balloon in the patients with Coronary Artery Disease.

STUDY DESIGN:

Prospective, Multi-centre clinical registry enrolls real world, all comers patients from the routine clinical practice at various Interventional Cardiology Sites. All patients have Clinical Follow-up at 1, 6 and 12 Months.

PRIMARY ENDPOINTS:

  • MACE (Major Adverse Cardiac Event) is a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion/vessel revascularization (TLR/TVR)) at 6 months.
  • Procedural success which is defined as technical and angiographic success in the absence of a Major Adverse Cardiac Event (MACE) at hospital discharge.

SECONDARY ENDPOINTS:

MACE (Major Adverse Cardiac Event) is a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion/vessel revascularization (TLR/TVR) at 12 months.

RESULTS

 

Total number of patients enrolled, N=424

 

Nanolute_Polpulation

 

PATIENTS’ DEMOGRAPHICS:

Patients, N 424
 Age, years ± SD   59.71 ± 10.50
 Male, (%)   81.84
 Cardiovascular risk factors, (%)  
 Diabetes   44.58
 Hypertension   46.93
 Family history of CAD   3.30
 Previous CV history, (%)  
 Myocardial Infarction  29.72
 Percutaneous Coronary Intervention  52.59
 Coronary artery bypass surgery  6.60
 Risk Factors, (%)  
 Peripheral vascular disease  0.47
 Renal Insufficiency  3.30
 Left Ventricular Dysfunction  5.42

 

Clinical Presentation

Nanolute_Clinical

 TARGET LESION CHARACTERISTICS:

Nanolute_TargetLesion

*PDA: Posterior Descending Artery, PLB: Posterior Lateral Branch, PLV/PLB: Posterior Left Ventricular Branch, OM: Obtuse Marginal

 

DEVICE CHARACTERISTICS:

SCB characteristics (mm ± SD)  
 Length, mm   2.68 ± 0.45
 Diameter, mm   22.31 ± 7.17
 Inflation pressure, bar   11.26 ± 7.34
 Inflation time, s   49.55  ± 25.62

 

CUMULATIVE CLINICAL OUTCOME AT 6 AND 12 MONTHS:

Nanolute_CO

 

* 418 patients have completed 6 months follow up

** 390 patients have completed 12 months follow up

 

 

SUBGROUPS

DE NOVO SMALL VESSEL DISEASE SUBGROUP

 

PATIENTS’ DEMOGRAPHICS:

Patients, N 191
 Female, (%)  17.28
 Male, (%)   82.72
 Cardiovascular risk factors, (%)  
 Diabetes  38.74
 Hypertension   43.98
 Previous CV history, (%)  
 Myocardial Infarction   8.90
 Coronary artery bypass surgery  4.19

 

DEVICE CHARACTERISTICS:

SCB Characteristics, mm ± SD 191
 SCB Diameter 2.33 ± 0.26
 SCB Length 21.84±7.26

 

CLINICAL PRESENTATION:

Nanolute_SG_CP

 

TARGET LESION CHARACTERISTICS:

Nanolute_SG_TV

PDA: Posterior Descending Artery, PLB: Posterior Lateral Branch, PLV/PLB: Posterior Left Ventricular Branch, OM: Obtuse Marginal

 

CUMULATIVE CLINICAL OUTCOME AT 6 AND 12 MONTHS:

Nanolute_SG_CCO

* 190 patients have completed 6 months follow up

** 174 patients have completed 12 months follow up

 

IN-STENT RESTENOSIS SUBGROUP

 

PATIENTS’ DEMOGRAPHICS:

Patients, N 191
 Age, years ± SD 59.71 ± 10.50
Male, (%) 79.58
Cardiovascular risk factors, (%)  
Diabetes 23.58
Hypertension 50.26
Previous CV history, (%)  
Myocardial Infarction 52.88
Coronary artery bypass surgery 7.85

 

CLINICAL PRESENTATION:

Nanolute_SG_Denovo_CP

 

 

ISR CLASSIFICATION:

Nanolute_SG_ISR_Classifications

 

TYPE OF STENT WITH ISR:

Nanolute_SGISR_TOS

 

CUMULATIVE CLINICAL OUTCOME AT 6 AND 12 MONTHS:

Nanolute_SG_ISR_CCO

* 186 patients have completed 6 months follow up

** 178 patients have completed 12 months follow up

 

DRUG ELUTING STENT- IN STENT RESTENOSIS (DES-ISR) SUBGROUP

Nanolute_SG_DESISR_

 

PATIENTS’ DEMOGRAPHICS:

Patients, N 150
Female, (%) 23.33
Male, (%) 76.67
Cardiovascular risk factors, (%)  
Diabetes 52.67
Hypertension 50.67

 

CLINICAL PRESENTATION:

Nanolute_SG_ISR_CP11

 

TARGET LESION CHARACTERISTICS:

Nanolute_SG_DESISR_TLC

 

CUMULATIVE CLINICAL OUTCOME AT 6 AND 12 MONTHS:

Nanolute_SG_DESISR_CCO

*146 patients have completed 6 months follow up

** 139 patients have completed 12 months follow up

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