## Protocol Section
### Identification Module
**NCT ID:** NCT01086579

**Acronym:** BELLO

**Brief Title:** Balloon Elution and Late Loss Optimization (BELLO) Study

**Official Title:** Balloon Elution and Late Loss Optimization (BELLO) Study: A Multicentre Randomized Study of the IN.PACT Falcon™ Paclitaxel Drug-eluting Balloon to Reduce Restenosis in Small Coronary Vessels

#### Organization Study ID Info
**ID:** BELLO
#### Organization
**Class:** OTHER
**Full Name:** Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
### Status Module
#### Completion Date
**Date:** 2014-05

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2013-08-14

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-08-13

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2012-03

**Type:** ACTUAL

#### Start Date
**Date:** 2010-03

**Status Verified Date:** 2013-08

#### Study First Post Date
**Date:** 2010-03-15
**Type:** ESTIMATED
**Study First Submit Date:** 2010-03-11
**Study First Submit QC Date:** 2010-03-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Prospective multicentre randomized (1:1) investigator initiated study, in which consecutive patients undergoing percutaneous revascularization of small coronary vessels will be assigned to one of the two study arms:

1. Treatment Arm: IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare-metal stenting (BMS).
2. Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice.

Eligible subjects with coronary artery disease in a small vessel (reference diameter\<2.8mm) will be consecutively screened and enrolled based on the inclusion and exclusion criteria

The objective of the study is to assess the non-inferiority of the DEB to the PES as regards to primary endpoint of mean late lumen loss (LLL) at 6 months, defined as the difference between postprocedural minimum luminal (MLD) diameter and follow-up MLD, as assessed by quantitative coronary angiography and is based on the following assumptions:

1. The means of LLL in the 2 groups are precisely equal
2. A standard deviation in LLL of 0.5mm in both groups as demonstrated in the ISAR-SMART 3 and PEPCAD II trials
3. A non-inferiority margin of 0.25mm between groups is clinically unimportant

Based on these assumptions:

1. Null hypothesis (N0): mean LLL in DEB group is ≥0.25mm than that in the PES group (i.e. PES is superior to DEB)
2. Alternative hypothesis 1 (H1): mean LLL between DEB and PES is \<0.25mm (i.e. DEB is non-inferior to PES)
3. Alternative hypothesis 2 (H2): mean LLL between DEB and PES \<0 (i.e. DEB is superior to PES) Based on the above calculations, a sample size of 77 patients will be required in each group to show non-inferiority of DEB vs. PES with an α error of 0.025 (one-sided Z test) and a power of 80%. To account for a 20% rate of withdrawal, lost to follow-up or not presenting for follow-up angiography, a total of 182 patients (91 in each group) will be randomized.

### Conditions Module

**Conditions:**

- Coronary Artery Disease

**Keywords:**

- paclitaxel PTCA drug-eluting balloon

- provisional spot stenting

- coronary artery disease

- Late Lumen Loss

- Minimal lumen diameter

- coronary artery disease in a small vessel

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 182

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare metal stenting (Bare Metal Stent).

**Intervention Names:**

- Device: IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)

**Label:** Treatment Arm (IN.PACT Falcon Drug Eluting Balloon)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice.

**Intervention Names:**

- Device: Taxus (Paclitaxel eluting stent)

**Label:** Control Arm PES

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment Arm (IN.PACT Falcon Drug Eluting Balloon)

**Description:** Coronary Artery Bypass Graft (CABG)

**Name:** IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)

**Other Names:**

- IN.PACT Falcon paclitaxel eluting balloon

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control Arm PES

**Description:** Percutaneous transluminal coronary angioplasty (PTCA) with stent

**Name:** Taxus (Paclitaxel eluting stent)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Late Lumen Loss (LLL) at 6 months follow-up defined as the difference between postprocedural minimum luminal diameter and follow-up minimum luminal diameter, as assessed by quantitative coronary angiography

**Time Frame:** 6 Month

#### Secondary Outcomes

**Measure:** Device Success: ability of the Investigational Device to be delivered, dilate, and be retrieved from the target lesion.

**Time Frame:** day 1

**Measure:** Procedural Success: defined as Device Success without the occurrence of Major Adverse Cardiac Events (MACE) during the index hospitalization

**Time Frame:** day 1

**Measure:** MACE rate through 30 days, 6 months,1, 2, 3 years post index procedure

**Time Frame:** 30 days, 6 months,1, 2, 3 years

**Measure:** Target Lesion Revascularization (TLR) at 6 months,1, 2, 3 years post index procedure

**Time Frame:** 6 months,1, 2, 3 years

**Measure:** Target Vessel Revascularization (TVR) at 6 months,1, 2, 3 years post index procedure

**Time Frame:** 6 months,1, 2, 3 years

**Measure:** Target vessel failure (TVF), defined as cardiac death, Myocardial Infarction (MI) or TVR at 1 year

**Time Frame:** 1 Year

**Measure:** Binary Restenosis rate at 6 months follow-up

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age \> 18 years.
* Patient providing written informed consent.
* Patients with stable angina pectoris (Canadian Cardiovascular Society \[CCS\] 1, 2 3) or unstable angina pectoris with documented ischemia (CCS 4, Braunwald Class IB-C, IIB-C or IIIB-C), or patients with documented silent ischemia.
* Patients who are eligible for coronary revascularization (angioplasty and/or CABG).
* Female patients with child bearing potential must have a negative pregnancy test within one week before treatment and must use adequate contraception.

Angiographic Inclusion Criteria:

* Native coronary artery.
* De novo lesion.
* Reference vessel diameter \< 2.8mm by visual estimate.
* Target lesion with a visually estimated stenosis \>50%.
* Target lesion length \< 25mm by visual estimate.
* A maximum of 2 epicardial vessels requiring revascularization.
* A maximum of 2 target lesions can be included (In the case of treatment of more than one lesion, the treatment selected will remain the same).

Exclusion Criteria:

* Patients unable to give informed consent.
* Patients enrolled in another study with any investigational drug or device within the past 30 days.
* Patients scheduled for a major surgical intervention within 6 months of enrolment in the study.
* Patients with acute (\< 24h) or recent (≤ 48 hours) myocardial infarction.
* Patients with a contraindication to an emergency coronary bypass surgery.
* Any individual who may refuse a blood transfusion.
* Patients with serum creatinine \>2.0mg/dL or \>180umol/L.
* Patients with severe congestive heart failure.
* Patients who had a cerebral stroke \<6 months prior to the Index Procedure.
* EF (Ejection Fraction) \< 30%.
* Patients with any known allergy, hypersensitivity or intolerance to acetylsalicylic acid (ASA), Clopidogrel or Ticlopidine, Paclitaxel.
* Any known allergy to contrast medium that cannot be pre-treated.

Angiographic exclusion criteria:

* \>2 epicardial vessels requiring revascularization.
* Target lesion distance from the ostium of left anterior descending coronary artery (LAD)/left circumflex coronary artery (LCX)/right coronary artery (RCA) is \< 5 mm.
* Target lesion is located in either a venous or arterial graft.
* Target vessel contains a previously implanted stent.
* Angiographic evidence of thrombus at the target site.
* Chronic total occlusions.
* Restenotic lesions.
* Bifurcation lesions which the operator decides a 2-stent technique as intention-to-treat is required OR bifurcations with side branches ≥ 2.5mm.
* Failure to successfully treat non-target lesions within the target vessel (non-target lesions must be treated prior the target lesion).
* Greater than 2 non-target lesions treated during the index procedure.
* Previous Percutaneous Coronary Intervention (PCI) within the last 3 months.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Milan

**Country:** Italy

**Facility:** Irccs Fondazione Centro S.Raffaele Del Monte Tabor

**State:** MI

**Zip:** 20100

#### Overall Officials

**Official 1:**

**Affiliation:** IRCCS Fondazione Centro S.Raffaele del Monte Tabor

**Name:** Antonio Colombo, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Presidio Ospedaliero Ferrarotto di Catania

**Name:** Corrado Tamburino, Prof.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Istituto Clinico Humanitas di Rozzano (MI)

**Name:** Patrizia Presbitero, Prof

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Azienda Ospedaliera Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi di Ancona

**Name:** Alberta Pangrazi, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 5:**

**Affiliation:** Azienda Ospedaliera San Camillo Forlanini di Roma

**Name:** Roberto Violini, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 6:**

**Affiliation:** Ospedale "C.Poma" di Mantova

**Name:** Francesca Buffoli, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 7:**

**Affiliation:** Azienda Ospedaliera "Bolognini" di Seriate

**Name:** Maurizio Tespili, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 8:**

**Affiliation:** Citta' di Lecce Hospital di Lecce

**Name:** Fausto Castriota, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 9:**

**Affiliation:** Villa Maria Cecilia Hospital di Cotignola

**Name:** Alberto Cremonesi, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 10:**

**Affiliation:** Villa Maria Eleonora Hospital di Palermo

**Name:** Antonio Micari, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 11:**

**Affiliation:** Casa di Cura "AntheaHospital" di Bari

**Name:** Alfredo Marchese, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 12:**

**Affiliation:** European Hospital di Roma

**Name:** Fabrizio Tomai, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 13:**

**Affiliation:** Ospedale S.Maria delle Croci AUSL di Ravenna

**Name:** Massimo Margheri, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 14:**

**Affiliation:** Azienda Ospedaliero-Universitaria di Parma

**Name:** Alberto Menozzi, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Latib A, Colombo A, Castriota F, Micari A, Cremonesi A, De Felice F, Marchese A, Tespili M, Presbitero P, Sgueglia GA, Buffoli F, Tamburino C, Varbella F, Menozzi A. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2473-80. doi: 10.1016/j.jacc.2012.09.020. Epub 2012 Nov 14. Erratum In: J Am Coll Cardiol. 2013 Apr 16;61(15):1660.

**PMID:** 23158530

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6549

- Name: Coronary Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M8219

- Name: Exanthema

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000003327

- Term: Coronary Disease

### Intervention Browse Module - Ancestors

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19537

- Name: Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017239

- Term: Paclitaxel

- ID: D000068196

- Term: Albumin-Bound Paclitaxel

### Misc Info Module

- Version Holder: 2024-05-24
